Tag Archives: quality

JOB: Mill Quality Leader | MS

Title: Mill Quality Leader

Job #767629, Kimberly-Clark Corp.

Location: Corinth MS

Function: Operations

Reports to: Mill Manager and dotted line to Business Sector Quality Lead

Position Purpose: 

Provide leadership and coordination for the quality management system, by ensuring ongoing compliance to FDA, ISO 9001, and corporate/sector quality requirements. Also to provide assistance and coordination as needed for issues relative to customer use of the materials and products produced by the mill, with emphasis on preventing customer issues or bringing problems or issues to root cause resolution.

Customers and Customer Expectations:

Customers: (1) Internal and External Customers who buy or use Nonwoven materials and products (2) Business Units; (3) Mill Management; (4) Mill Associates and Resources; (5) Corporate and GNW staff

Customer Expectations: (1) Ensure ongoing mill compliance to the FDA, ISO 9001, and Corporate and Sector quality management systems requirements. (2) Ensure any deviations or nonconformances are effectively resolved; (3) Drive continuous improvement in the mill’s quality and customer service performance and in the quality management system (4) Assist with customer related issues and ensure timely and effective resolution

Scope:

  • Will be the appointed Quality Management representative for the Corinth Mill and has the responsibility and authority to:
    • Ensure processes needed for the Quality Management System are established, implemented, and maintained.
    • Report to management on the performance of the quality management system and any needed improvements.
    • Ensure the promotion and awareness of regulatory and customer requirements.
  • Works in concert with other Quality Management Representatives to provide a coordinated effort for common Quality Management Systems across the Global Nonwovens sector while ensuring that the Corinth Mill meets FDA, ISO 9001, and sector and corporate quality requirements.
  • Leads or is highly involved in continuous improvement efforts for sector quality initiatives
  • Works with customers and manufacturing teams to ensure satisfaction with the materials and products produced and effective resolution to customer satisfaction issues.
  • Fulfills the role of:
    • The Management Representative as defined in ISO 9001:2008
    • 21 CFR 820, section 820.20 (3) Management Representative
    • MHLW Ministerial Ordinance No. 169, 2004, Article 65 Responsible Engineering Manager
    • Other regulations or standards which require a Management Representative to be the individual responsible for the location Quality Management System and supporting quality activities designed to comply with applicable regulations and/or standards.

 

Qualifications/Education/Experience Required:

  • Requires knowledge and ability typically associated with a college education related to quality, engineering, statistics, and/or at least 3 years of operational leadership in a manufacturing environment.
  • The incumbent must be able to communicate with customers at all levels from the Mill Manager to the person on the manufacturing floor and possess communication skills for all situations.
  • Must have working knowledge of quality system requirements and ability to ensure ongoing compliance.
  • This person typically has an in-depth knowledge of a single functional area and a working knowledge of many areas.
  • Must be able to travel an appropriate amount of time in order to have a firsthand knowledge of our customers and their processes (<25% expected).

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

PRINCIPAL ACCOUNTABILITIES:

  • Act as the Quality Management Representative.
  • Maintain and enhance the Quality Management System to ensure ongoing compliance with the FDA Medical Device, ISO 9001 requirements, as well as the Corporate and sector Quality Management System Requirements.
  • Act as host for the ISO, FDA, Corporate, or GNW Sector Quality Audits.
  • Manage the Internal Assessment, Management Review, Complaint Handling, and Corrective/Preventative Action process.
  • Provide direction and coordination of efforts of the Quality Assurance Resources to ensure overall effectiveness in Quality Assurance support of the manufacturing departments and to proactively identify and execute quality improvement programs.
  • Provide direction and coordination of the Customer Service Coordinator to ensure overall effectiveness and timeliness in complaint investigation and resolution. Encourage and drive mill teams to take ownership of customer satisfaction and to proactively execute customer service improvement programs. Through networking with customers, the mill teams, and the other Nonwovens Mills, anticipate potential customer service issues and drive to resolution.
  • Accountable for ensuring design transfer activities for product/process changes occurs to ensure critical to quality variables meet quality capability and consistency goals.
  • Accountable for getting to root cause of Operational Customer Quality Events and Major Quality Nonconformances.
  • Responsible for developing process verification/validation skills within the R&E teams and Mill teams.
  • Involved in the maintenance and updates to design history and risk management files.
  • Participate in the GNW Sector Quality Capability Team and other Sector teams as needed to drive standardization and business systems improvement across the board, such as the Change Control Team.
  • Support the mill’s EHS policy; comply with all local EHS legislation and codes; identify, report, investigate and address any EHS substandard acts and/or conditions; and drive the setting of EHS objectives and evaluate the effectiveness of the mill’s EHS Management System.
  • Ensure the communication, implementation, and promotion of the World Class Manufacturing values, vision, mission, and foundations as a means for delivering manufacturing results.
  • Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship.

 

Global VISA and Relocation Specifications:

K-C will support global relocation for the chosen candidate for this role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion. Compensation may vary by location.

 

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

 

 

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JOB: Mill Quality Leader | MS

Title: Mill Quality Leader

Job #767629, Kimberly-Clark Corp.

Location: Corinth MS

Function: Quality & Regulatory Affairs

Reports to: Technical & Quality Team Lead

Position Purpose: 

Provide leadership and coordination for the quality management system, by ensuring ongoing compliance to FDA, ISO 9001, and corporate/sector quality requirements. Also to provide assistance and coordination as needed for issues relative to customer use of the materials and products produced by the mill, with emphasis on preventing customer issues or bringing problems or issues to root cause resolution.

Customers and Customer Expectations:

Customers:  (1) Internal and External Customers who buy or use Nonwoven materials and products (2) Business Units; (3) Mill Management; (4) Mill Associates and Resources; (5) Corporate and GNW staff

Customer Expectations:  (1) Ensure ongoing mill compliance to the FDA, ISO 9001, and Corporate and Sector quality management systems requirements. (2) Ensure any deviations or nonconformances are effectively resolved; (3) Drive continuous improvement in the mill’s quality and customer service performance and in the quality management system (4) Assist with customer related issues and ensure timely and effective resolution

Scope:

  • Reports to the Mill Manager and has dotted-line accountability to a Business Sector Quality Leader.
  • Will be the appointed Quality Management representative for the Corinth Mill and has the responsibility and authority to:
    • Ensure processes needed for the Quality Management System are established, implemented, and maintained.
    • Report to management on the performance of the quality management system and any needed improvements.
    • Ensure the promotion and awareness of regulatory and customer requirements.
  • Works in concert with other Quality Management Representatives to provide a coordinated effort for common Quality Management Systems across the Global Nonwovens sector while ensuring that the Corinth Mill meets FDA, ISO 9001, and sector and corporate quality requirements.
  • Leads or is highly involved in continuous improvement efforts for sector quality initiatives
  • Works with customers and manufacturing teams to ensure satisfaction with the materials and products produced and effective resolution to customer satisfaction issues.
  • Fulfills the role of:
    • The Management Representative as defined in ISO 9001:2008
    • 21 CFR 820, section 820.20 (3) Management Representative
    • MHLW Ministerial Ordinance No. 169, 2004, Article 65 Responsible Engineering Manager
    • Other regulations or standards which require a Management Representative to be the individual responsible for the location Quality Management System and supporting quality activities designed to comply with applicable regulations and/or standards.

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

Qualifications/Education/Experience Required:

  • Requires knowledge and ability typically associated with a college education related to quality, engineering, statistics, and/or at least 3 years of operational leadership in a manufacturing environment.
  • The incumbent must be able to communicate with customers at all levels from the Mill Manager to the person on the manufacturing floor and possess communication skills for all situations.
  • Must have working knowledge of quality system requirements and ability to ensure ongoing compliance.
  • This person typically has an in-depth knowledge of a single functional area and a working knowledge of many areas.
  • Must be able to travel an appropriate amount of time to have a firsthand knowledge of our customers and their processes (<25% expected).

PRINCIPAL ACCOUNTABILITIES:

  • Act as the Quality Management Representative.
  • Maintain and enhance the Quality Management System to ensure ongoing compliance with the FDA Medical Device, ISO 9001 requirements, as well as the Corporate and sector Quality Management System Requirements.
  • Act as host for the ISO, FDA, Corporate, or GNW Sector Quality Audits.
  • Manage the Internal Assessment, Management Review, Complaint Handling, and Corrective/Preventative Action process.
  • Provide direction and coordination of efforts of the Quality Assurance Resources to ensure overall effectiveness in Quality Assurance support of the manufacturing departments and to proactively identify and execute quality improvement programs.
  • Provide direction and coordination of the Customer Service Coordinator to ensure overall effectiveness and timeliness in complaint investigation and resolution. Encourage and drive mill teams to take ownership of customer satisfaction and to proactively execute customer service improvement programs. Through networking with customers, the mill teams, and the other Nonwovens Mills, anticipate potential customer service issues and drive to resolution.
  • Accountable for ensuring design transfer activities for product/process changes occurs to ensure critical to quality variables meet quality capability and consistency goals.
  • Accountable for getting to root cause of Operational Customer Quality Events and Major Quality Nonconformance.
  • Responsible for developing process verification/validation skills within the R&E teams and Mill teams.
  • Involved in the maintenance and updates to design history and risk management files.
  • Participate in the GNW Sector Quality Capability Team and other Sector teams as needed to drive standardization and business systems improvement across the board, such as the Change Control Team.
  • Support the mill’s EHS policy; comply with all local EHS legislation and codes; identify, report, investigate and address any EHS substandard acts and/or conditions; and drive the setting of EHS objectives and evaluate the effectiveness of the mill’s EHS Management System.
  • Ensure the communication, implementation, and promotion of the World Class Manufacturing values, vision, mission, and foundations as a means for delivering manufacturing results.
  • Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship.

Global VISA and Relocation Specifications:

K-C will support global relocation for the chosen candidate for this role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion. Compensation may vary by location.

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

Kimberly-Clark seeks a Sr. Director of Product Safety and Clinical Affairs

KC-Unleash

Title:   Senior Director Global Product Safety and Clinical Affairs

Company: Kimberly-Clark Corporation, Job #1500006V

Location: Neenah WI or Roswell GA

Function: Global Safety, Quality and Sustainability

Reports to: VP Global Quality & Regulatory

Scope: global

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 150 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With a 135-year history of innovation, we believe in recruiting the best people and putting them in the right jobs so that they can do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.
Position Summary:

This team leader position reports to the Vice-President of Global Quality and is responsible for providing executive leadership to two global teams – Global Clinical Affairs and Global Product Safety. The incumbent will lead these organizations with the remit of ensuring that all Kimberly-Clark products and services sold worldwide are substantiated as safe for their intended use, governmental product safety regulations and meet Company policies and standards and developing clinical evidence and clinical education programs (if needed) in support of the achievement of business strategies and objectives.

Product Safety and Clinical services are provided to all Corporate Functions, Business Sectors and Equity Affiliates of the Corporation worldwide. Management, technical leadership and professional development is provided to team leaders, senior professional and supporting Product Safety, Product Stewardship and Clinical Affairs staff located in Neenah, Roswell, Reigate, JukJeon and other regions as needed.

The incumbent is required to lead a team to  develop and sustain a Global Product Safety approach and clinical strategies that ensure state-of-the-art toxicological  and clinical expertise,  assessments, trials processes and systems are applied that not only ensure product and human safety, but also drive product innovation, sustainability and speed-to-market. The incumbent provides advice to business units based on scientific principles of human health risk assessment or environmental impact with emphasis on helping K-C businesses find viable options and alternatives that are both safe and help achieve Corporate business objectives.

Principal Accountabilities:

  •   Provide consultative, investigative and research services to identify characteristics in the materials and design of Kimberly-Clark products and clinical trials to ensure safety, regulatory and corporate standard compliance.  Recommend steps as necessary to ensure the safety and efficacy of these products and trials thereby minimizing customer dissatisfaction and/or corporate liability and to develop alternative testing methodologies, which can safely be utilized in K-C products and clinical strategies.
  •   Develop, maintain and improve control systems and procedures that ensure that new materials or products are adequately reviewed for their safety prior to authorization to market. Integrate the K-C Product Safety system into the Innovative Management Framework and other Product Development processes so that these systems function efficiently.
  •   Maintain an awareness of the constantly changing safety, regulatory and medico-legal requirements, translating them into consistent, comprehensive policies and strategies and implementing them to ensure products are safe for both the corporation and its customers.
  •   Ensure awareness of newly described potentials for adverse safety effects relating to the Corporation’s products or product components. Recommend actions to resolve adverse impact upon the Corporation.
  •   Ensure expertise, processes and systems are in place to conduct due diligence on behalf of the Company as required.
  •    Develop and administer a system for receiving, storing, and retrieving confidential information from vendors, suppliers and/or customers as necessary for safety evaluation of K-C products. Ensure that the confidentiality of this information is maintained both within and outside the Corporation.

Interested?  You can also contact Dorothy.Beach@KCC.com to receive more information.   Sending your resume can allow a more intelligent discussion between your career goals and Kimberly-Clark’s business needs.

Qualifications:

  • The ideal candidate will have 15+ years of experience in increasingly senior quality positions within the medical device and/or consumer packaged goods industry. S/he must have an excellent understanding of FDA’s quality frameworks as well as a strong network of relationships with its senior representatives. The successful candidate will also have significant expertise working with continuous improvement methodologies, such as Lean and Six Sigma. S/he must possess a thorough knowledge of current quality trends and concepts and be able to determine appropriate solutions to a wide variety of regulatory and quality problems across the company. Finally, demonstrable results in leading a ground-up review of a quality system would be highly valued.
  • The successful candidate for this role will also have a bachelor’s degree from a recognized university, preferably in engineering or the sciences. An MBA or an advanced degree in sciences/engineering would be preferred.

In addition to the above, we would expect the following specific competencies:

o   Technical Expertise. The successful candidate must be technically credible and possess proven experience dealing with all aspects of product safety product safety-related regulatory requirements, and is also knowledgeable of Human Subject Testing and Good Clinical Practices / Code of Federal Regulations (CFRs).

o   Results Orientation. Executives demonstrating this competency have a track record of delivering against a plan and budget. The individual will be energized by a challenge, and will seek out ways to consistently exceed his/her goals. This person will have demonstrated that s/he takes ownership and responsibility for commitments and is able to deliver despite constraints or unexpected obstacles.

o   Collaboration and Influencing. The successful candidate must have demonstrated the ability to effectively work in a global and complex organization and as part of an international team and a multicultural environment. S/he must be able to adapt his/her influencing style to different personality types as well as different business and national cultures. Furthermore, s/he must also facilitate collaboration among others. This means actively engaging colleagues and business partners to make joint decisions, share best practices, and bring internal and external people together across geographical and organizational boundaries to achieve world-class quality results.

o   People Leadership & Development. The successful candidate will be an inspiring people manager who is able to motivate team members. This individual will work through people and groups and empower them, measure their performance, and hold them accountable for their results. This executive will have demonstrated the ability to tailor his/her style and approach to the situation, the cultural environment, and the individual, exhibiting directive or collaborative behavior as circumstances require. Finally, the successful candidate will show the ability to develop the competencies of the organization by acquisition of top talent and development of their team; they find deep satisfaction in knowing they have made an impact on an individual’s life or career.

 

Travel: Approximately 25% of time; international travel required.

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Kimberly-Clark HC hiring Plant Manager for Tijuana MX site

Halyard icon

Title:  Plant Manager – Tijuana, MX – Live in US and Cross Boarder Daily

Company: Halyard Health/ Kimberly-Clark Corporation

Location: Tijuana Plant in Mexico

Function: Operations

Reports to: Director

Product Line: medical devices

Kimberly-Clark Health Care provides a portfolio of solutions that improve the health, hygiene and well-being of patients and clinicians around the world. With significant expertise in the areas of infection prevention, surgical protection, respiratory health, digestive health and pain management, Kimberly-Clark Health Care is driven to produce innovative solutions that improve both medical outcomes and business performance. Kimberly-Clark plans to spin-off Kimberly-Clark Health Care by year-end into Halyard Health, a stand-alone, publicly-traded healthcare company with leading market positions in surgical and infection prevention products and medical devices. This is the time to consider an exciting opportunity with a company committed to advancing health and healthcare by preventing infection, eliminating pain and speeding recovery. If you are inspired by the opportunity to transform healthcare delivery, join the Kimberly-Clark Health Care team! 

Position Purpose:

Lead and manage Tijuana operations’ capability and performance to help Health Care achieve its net sales, operational profit and gross margin objectives by meeting product supply sector goals.  Incumbent will be on US Payroll but required to work in Tijuana, Mexico

Expectations:

  • Ensure that Tijuana organizations establish and meet objectives in safety, quality, cost, productivity, customer service, asset management, force savings, lean manufacturing, and human resource development to achieve vision 2015.
  • Product Supply manufacturing activities are integrated with Go to Market strategies.
  • Provide effective leadership to encourage continuous improvement and Lean certification.
  • Provide leadership in the prioritization and implementation of capital budgets
  • Lead and manage a manufacturing culture based on high performance work teams.
  • Ownership in the implementation of new production lines and the launch of product into the market.
  • To own the effectiveness of the Quality Management System in Tijuana.

Scope:

Incumbent reports to the Health Care Director for Medical Devices. He/she has broad management responsibilities for manufacturing and manual processes related to Medical Device manufacturing. The incumbent provides leadership for the Tijuana operation team to meet challenges faced by manufacturing while achieving goals and objectives.  The role has line operations accountability and requires internal and external coordination of projects and programs for successfully implementation within Health Care guidelines and expectations.

The main challenge of this position is to effectively influence across functional areas in an integrated manner within Global Health Care to ensure successful implementation of line operations and cost saving activities

Interested?  Please send your resume to Dorothy.Beach@KCC.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

 

Basic Qualifications:

 

  • This position requires knowledge and ability typically associated with a bachelor’s degree, or equivalent training and experience
  • The incumbent also must have broad knowledge and significant experience in operations/ logistics/maintenance or related areas at the functional level
  • A working knowledge of multifunctional issues including Mexican labor law, customs regulations, EPA/OSHA regulations and their Mexican counterparts.
  • This person requires a thorough understanding of all internal and external mill/plant functional areas and their interaction, and a proven ability to work across all staff functions

 

Preferred Qualifications:

  • Ability to speak Spanish and English
  • 5 plus years of experience in manufacturing of Medical Devices

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Senior Manager Sustaining Engineering | CA

 

KC-Unleash

Title: Senior Manager Sustaining Engineering   

Job #14000002, Kimberly-Clark Corp./ iFLOW

Location: Lake Forest CA near Los Angeles

Function: Engineering

Reports to: Director R&E

From brands such as Huggies® and Kleenex® to medical devices and workplace solutions, Kimberly-Clark makes the essentials for a better life. We hold the No. 1 or No. 2 share position globally in more than 80 countries, but we’re not just changing diapers here. Our employees are changing the world for the better with innovative products that create new categories and push existing ones to a higher level. If fresh thinking and a passion to win inspire you, Come Unleash Your Power at Kimberly-Clark!

 

Who are we?
We are the leading provider of post-surgical pain solutions in the United States, and we are looking for a top-flight candidate to build a best-in-breed Sustaining Engineering group within our Research and Engineering department. 

Are you on board with our values?

Build Trust: Are you open and candid, and do you value diverse perspectives and debate?
Make Decisions: Are you focused and driven? Do you have the courage to make hard choices?
Win Consistently: Do you expect to win by delivering near- and long-term results?
Think Customer: Do you work every day to understand and anticipate your customers’ needs?
Continuously Improve: Do you break down boundaries for new ideas to improve the business?
Build Talent: Are you accountable for building a strong team and strong self-development?

If you answered “Yes!” to all of the above, then you’re ready to come on board and join us as we kicking off an exciting new chapter in our company’s history.

Position Summary
This individual will bring leadership and talent management to the sustaining engineering group as well as the shared CAD and laboratory services groups. You will work with your team and build a cross-functional alliance with product supply, quality, operations, marketing, sales, and our constellation of vendors and supporting groups to continually evaluate our current product lines and search for opportunities for improvement. You will keep an eye toward quality, cost reductions, product flow and look hard at every opportunity we have to improve the way we do business. You will build and manage a group of program managers and engineers, ensuring that priorities are properly set and commitments are met in an organized and disciplined way. You will oversee the shared services groups and make sure they are properly staffed, efficient, and their talent pools are nurtured to provide value at every stage of the programs they affect. You will have a positive, driven approach to leadership that allows you and your team to build and sustain close relationships with one another, your R&D teammates and cross-functionally throughout the entire $1.6B organization.

Essential Duties and Responsibilities
• Provide leadership and management for companywide efforts in sustaining and operational engineering programs.
• Oversee the development and execution of a portfolio of programs, taking ownership of the prioritization, assignments and commitments related to each.
• Ensure programs in the sustaining engineering department come to completion on time, within budget, and with exemplary quality.
• Oversee the shared services groups, ensuring that the work flow managers have the correct and consistent priorities with respect to the goals of the overall business and that work that comes from those groups is the highest quality and value-add to their respective programs.
• Provide guidance and leadership to the New Product Development group on smooth and successful flow of new products in to the operational and sustaining value stream.
• Ensure successful cross-functional relationships with stakeholders across the company.
• Ensure the team has the right skills and experiences in order to provide broad technical support to the existing IFlow business.
• Ensure team and individual development activities conform to medical device regulations and corporate policies.
• Communicate effectively with superiors, subordinates and others. Articulate and translate visions to assist others in understanding goals and objectives in a way that is timely, complete, concise, and candid.
• Model the One KC Behaviors while being an advocate and key contributor in delivering the business results.
• Actively work to attract, retain, and develop top talent for Health Care R&E, and manage self and team in accordance with the expected One KC behaviors.

Interested? You can contact Dorothy.Beach@KCC.com to receive more information on job # 14000002 .   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

Qualifications
• Bachelor’s degree in science or engineering, with a graduate degree in either engineering or business preferred.
• Over 10 years of experience in R&D, manufacturing or other technical function; demonstrating significant leadership experience managing cross-functional teams to successful outcomes.
• Technical leadership in an engineering environment and knowledge of advanced business, engineering, and management processes to drive success (LEAN, six-sigma, various statistical methods, critical chain, etc.)
• Demonstrated success in medical device, biotechnology or experience in similarly-regulated industries is required.
• Demonstrated and quantifiable track record in leadership, mentoring, and/or building talent.
• Knowledge of manufacturing systems and technologies as related to polymers, elastomers, and assemblies comprising the same.
• A clear and proven understanding of the product development process, product introduction, quality manufacturing, and design control system.

Preferred Qualifications
• Experience with ISO standards.
• Experience in working with sales and marketing and showing a commitment to business growth.
• Experience in vendor management and negotiation.
• Experience with Design for Manufacturability.
• Experience with electro-mechanical assemblies, or manufacturing of integrated electrical systems. 

Kimberly-Clark seeking Manufacturing Quality Director, NA | WI

Kimberly-Clark seeking Manufacturing Quality Director, NA | WI

Title:  Quality Director, North American     

Job #17053

Location: Neenah WI (http://bit.ly/FoxCitiesVideo)

Function: Fem/Senior Marketing

Reports to: Product Supply Lead

Abbreviated description.

Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 57,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $20.8 billion in 2011. Kimberly-Clark’s global brands are sold in more than 175 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

Summary of Position:

This position has responsibility for developing and implementing programs, capabilities and initiatives that create the overall quality and regulatory system for the North American AFC business and drive performance and ensure regulatory compliance as it relates to product and process quality.  The incumbent is a key leader in creating capability that ensures compliance, effectively manages risk and enables targeted speed of innovation to market for the North American AFC business.

Organization: People, Responsibilities, reporting and Partnerships:

•           Direct reports: TBD (anticipated 10 exempt; 1 non-exempt)

•           Key relationships include North American AFC Product Supply leader, senior AFC R&E leaders, brand champions, consumer services, material suppliers, procurement, third party manufacturers, plant operations (consumer and health care), corporate quality, corporate communications, legal and FDA.

Key Responsibilities:

•           Provide expert leadership and consultation to senior AFC leaders and plant managers to create an environment of (1) winning products at shelf and with consumers, (2) minimum variability, and (3) regulatory compliance.

•           Develop, articulate and implement quality management strategies that ensure quality and regulatory capability is an enabler and competitive advantage for AFC to meet business objectives and innovate in the marketplace at targeted speed to market.

•           Through training and capability development, ensure a ready and able pool of both functional and broader business talent exists to meet current and future quality and regulatory needs of the AFC business.

•           Demonstrate understanding and provide visibility of industry trends, emerging regulatory requirements and best practices via benchmarking internally and externally and integrate into execution of business-specific quality strategies.

•           Establish quality processes based on prevention, leading indicators and process management that can be owned and managed at the asset/crew level.

•           Establish and manage a comprehensive consumer complaint management, analysis and remediation process.

•           Ensure consistent application of quality standards, governmental and corporate requirements for current and future products.

•           Provide leadership and oversight to continually improve plant operations effectiveness and functionality in the areas of quality and regulatory compliance

•           Develop and deliver training to plant and staff that focuses on optimization of quality and regulatory systems and practices. 

•           Represent AFC for quality and regulatory matters both internally and externally, including a strong and active partnership with the FDA.

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: https://bitly.com/17053-QualSupp   and it will be reviewed within several business days 

Basic Qualifications

•           Position requires an undergraduate degree.

•           More than fifteen years of quality and regulatory-related experience

•           Experience in FDA-regulated personal care consumer products manufacturing operating in both a plant and corporate environment

•           Ability to travel by ground and air up to 50% of the time.

Preferred Qualification:

•           MBA or MS as well as certain industry and ISO certifications

•           Experience with Lean / Continuous Improvement tools and methodologies and third party manufacturing. 

•           Demonstrated experience interacting with FDA and leading in an environment subject to FDA-regulated governance

Technical Quality Systems Mgr – Global or Multi-site | GA

Title:  Technical Quality Manager   

Job #15166, Kimberly-Clark

Location: Roswell GA

Function: KC Professional R&E

Reports to: Director

 

Abbreviated description.

 

Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 57,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $20.8 billion in 2011. Kimberly-Clark’s global brands are sold in more than 175 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

 

Scope:

This position reports to the Director, Quality Assurance and Regulatory Affairs – KCP and has supervisory responsibilities for the Design Control, Change Control, Copy Approval, Training systems and personnel.  The incumbent is responsible for supporting KCP projects, system development; cost optimization, improved performance, and quality improvement initiatives.  Incumbent provides technical knowledge and guidance to KCP Business Teams as required to meet global Innovation and New Venture as well as product supply objectives.

 

Accountabilities:

1)         Provide global technical quality leadership in design control, change management, document control, copy approval systems; management review system and activity; and training systems to support the development of KCP technical quality systems to meet sector business unit objectives.

2)         Lead and coordinate problem solving situations at KCP and/or with suppliers on KCP change management issues.  Provide advice and counsel to KCP R&E groups and mills on change management procedures and process improvements for regulatory compliance purposes.

3)         Support cost improvement programs to achieve sector/mill cost objectives.

4)         Support specification development which ensures safe, effective, and reliable KCP products.

5)         Establish and maintain internal control within area of responsibility as required by KCP Internal Control policies.

etc

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/15166-QualMgr .  You can also contact Dorothy.Beach@KCC.com to receive more information on job # 15166 .   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

 

Qualifications/Education/Experience Required:

 

Requires a Bachelor’s degree in a science, engineering statistics or related discipline and 10+ years broad managerial experience in a Research, Manufacturing, Quality or Regulatory Affairs function.

An advanced degree is desirable. 

Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions. 

In-depth knowledge of applicable regulatory authority requirements for one or more of the following: biocides, personal protective equipment, cosmetics, drugs or medical devices. 

Also required is demonstrated evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels. 

ASQ-CQE, CQM or CRE highly recommended.

 

Manufacturing Engineers – Do you want to be a part of a Sustainability Goal?

Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend we have a responsibility to attain a deeper understanding of our impact on the world.   Addressing Sustainability issues and incorporating solutions through all levels of Kimberly-Clark is a critical component of our business:  http://bit.ly/K-C-SustainVideo . Our goal is to create a better future through People, Planet and Products (Green Done Right).

 

Kimberly-Clark has set aggressive goals to make our mills and other manufacturing plants more sustainable but we need the best talent to do it.  Today we have various levels of engineering roles open, some of which are corporate and others in our paper mills in WI, GA, TN, OK and MS.   Get details on these jobs by using this link in IE: http://bit.ly/WorkingHere   and choose the “Job Category” of Operations/Manufacturing Management or Logistics/Supply Chain.  Many titles have “Continuous Improvement” and “Lean Manufacturing” in them.  We seek candidates that are familiar with Lean tools such as Value Stream Mapping, Five S, Kanban (pull systems), and poka-yoke (error-proofing).  For Continuous Improvement we seek certifications in Six Sigma on various levels using various tools such as Control Charting, Root Cause Analysis, Process Capability among others.

Don’t see anything that fits your current career plans?  Add your resume to our database using this link –  http://bit.ly/K-C_CareersWW because we will have many more jobs opening up in the near future that might be a better fit.  If you get into our database then you can be found by recruiters!

 

Some basic requirements and “nice to haves”:

  • Bachelor’s degree in engineering is required for all jobs
  • Experience with Lean tools or Continuous Improvement tools depending on the role and sometimes BOTH
  • Total minimal experience of about 10 years in a manufacturing environment required for all jobs and 3-5 years in either CIP or Lean roles
  • SixSigma certifications are sometimes required

 

Thanks for your consideration and if you do apply or just post your resume please indicate where you found this job announcement.

Reg Affairs & QA Director for GA | Kimberly-Clark hiring

Title:  Director of Regulatory Affairs & Quality Assurance

Job #13017

Location: Roswell GA (http://bit.ly/Roswell-Green )

Function: Quality Assurance/ Regulatory/Compliance

Product Line: KC-Professional (http://bit.ly/K-C_Professional)

 

Kimberly-Clark (NYSE:KMB) is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

 

POSITION PURPOSE:
Responsible to develop, implement and maintain global KCP quality and regulatory systems. Collaborate with regional and corporate teams to ensure KCP globally meets all quality system and regulatory requirements. Drive improvement in business processes where quality and regulatory involvement is needed, and advance KCP regulatory interests with key internal and external stakeholders.

CUSTOMERS AND CUSTOMER REQUIREMENTS:
Key customers include consuming customers, sector management, business teams, R&E teams, product supply and quality assurance teams, corporate regulatory affairs and quality assurance teams, external quality and regulatory bodies.

Effective performance in this role will require:
– Strong collaboration, communication and persuasiveness skills
– Credibility with senior leadership internally and regulatory agencies externally
– Working effectively across functional and geographic boundaries through influence
– Visionary and strategy development skills
– Business acumen – a clear understanding of the business needs and key imperatives
– Experience / aptitude for process re-design and organizational change management
– Global breadth of experience and understanding
– Quality systems background

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/13017-DirRA-QA  .  You can also contact Dorothy.Beach@KCC.com to receive more information on job #13017.   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

 

Basic Requirements:

– A minimum of a Bachelor’s Degree in a relevant field is required.
– Requires a minimum of 8-10 years experience in an industry dealing with relevant regulatory requirements and leading regulatory or quality systems implementation and management.
– Experience having led or created a team and highly developed leadership capabilities combined with the ability to motivate and lead a diverse team and work in a matrix organization.

PREFERRED QUALIFICATIONS:
– Knowledge of KCP products, processes, and organization or similar industry experience is preferred
– Experience with ISO certification
– Experience with global regulations across multiple countries

K-C looking for a Medical Device TQM Engineer for Lake Forest CA

Position: Sr. Quality Engineer , #11919

Location: Lake Forest CA
Reports to: Director, Global Quality Operations

Kimberly-Clark (NYSE: KMB)  -Healthcare Division provides quality and innovation to enhance people’s health outcomes. We are heavily investing in enhancing our medical device businesses through development of new products and acquisition of medical device companies. Every day, 1.3 billion people in more than 150 countries – nearly a quarter of the world’s population – trust Kimberly-Clark brands and the solutions we provide to enhance their health, hygiene, and well-being. With a 135-year history of success and financial stability, we believe in recruiting smart people and supporting them so that they can do their best work.  In 2009 Kimberly-Clark acquired I-Flow Corporation a leader and innovator in pain management and drug delivery technology for physicians and their patients.

Summary: Conduct quality engineering activities to support the design and development process as well as other quality engineering elements to ensure compliance with I-Flow Quality System. Information on the product line is here: http://bit.ly/iFLOW-products.

Interested for you or a friend?  Please contact me at Dorothy.Beach@KCC.com or leave a message at 469-665-5639 to set up a time to talk. Please refer to job #11919.  You can also directly apply for job #11919 at http://bit.ly/11919-QualEngr after setting up a profile.
Responsibilities:
1. Develop, document, implement and report on the verification and validation of new product and their accompanying processes if applicable.
2. Responsible for supplier assessment oversee outside supplier’s quality.
3. Develop Quality plans for new materials, components and finished medical devices.
4. Demonstrated knowledge and experience with QSR, ISO 13485/ ISO 14791 and MDD.
5. Review Overall manufacturing process and Quality System elements for continuous improvement.
6. Knowledge of failure analysis, (FMEA-Process & Product Design)
7. TQM and SPC (statistical process control), FDA Quality System Regulation.
8. Work with suppliers of material, component or design changes to ensure timely implementation and quality.
9. Create product in process and final inspection procedures that define methodologies used for determining the level of process and product integrity based on all applicable requirements and specifications.
10. Provide receiving inspection with written instruction for inspecting components and assemblies.
11. Support product complaint investigation by performing failure and root cause analysis on products returned from the field.
12. Originate corrective and preventive actions (CAPA) and assist in the implementation of CAPA program.
13. Develop new approaches for solving problems identified during quality assurance activities
14. Support technical and administrative workers engaged in Quality Assurance activities.
15. Lead the MRB in the reporting & disposition of nonconforming materials. Maintain NCMR (non-conforming materials) database. Review corrective actions on NCMRS for adequacy to maintain a continuing awareness of quality issues.
16. Maintain the calibration database system. Assure timeliness and adherence to calibration schedules and equipment. Provide guidance to Mexico operations.
17. Review Protocols and Reports for Process/Product Validations for compliance with procedures.

Basic Qualifications:
Education: Bachelors Degree, CQE Certification desirable

Experience: Three years of related experience in the medical device industry. Analytical, detail oriented team player. Excellent communication, problem solving and project management skills.

Specialized
Knowledge: Microsoft windows (Excel, Word, Outlook). FDA QSR, MDD 93/42/EEC, ISO 13485/ ISO 14791, CMDR, GHTF-Process Validation Guidance.

There is no relocation assistance for this job and local, Southern California residents should apply.  Equal Opportunity Employer.