Tag Archives: ISO

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!

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Halyard Health hiring Compliance Audit Lead | GA

Halyard logo

Title:  Compliance Audit Leader (technical SME)

Company: Halyard Health/ formerly of Kimberly-Clark Corporation

Location: Alpharetta GA

Function: Quality Assurance, Regulatory & Compliance

Reports to: Director

Scope: Global – Manage a team of 5-10 reports (indirectly)

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

Role summary

Role will manage the overall Internal Manufacturing or Supplier Compliance Audit program across Halyard Health Inc., including but not limited to:

  • Manage and continuously improve the Internal Manufacturers or the Supplier Compliance audit process globally
  • Facilitate and provide guidance and direction related to compliance activities including alignment with new regulations
  • Coordinate cross-functional teams in the development and execution of compliance programs, evaluate facility audit programs and special technical gap assessments
  • Develop and maintain metrics associated with the Compliance program
  • Act as global Internal Manufacturer or Supplier QA Compliance SME
  • Assure the integrity and reliability of information systems and the Halyard Health Compliance Audit Schedule and risk assessment process, evaluate, approve and monitor corrective actions derived from the compliance audits
  • Coordinate as needs joint audits and special compliance gap assessments with other groups, facilitate FDA readiness training for internal manufacturers
  • Support FDA and external audit activities across Halyard locations;
  • Identify issues and drive internal manufacturing compliance improvements to ensure efficient regulatory compliance and reduced compliance risk and recommend compliance improvements needed with regular suppliers and contract manufacturers
  • Assess and qualify supplier and evaluate risk associate with transfer activities between internal manufacturers, new acquisitions and suppliers
  • Act as a SME coach to drive compliance activities across different locations

The incumbent will:

• Manage the Internal Manufacturing and/or the Supplier Compliance Audit program and compliance activities
• Facilitate multi-site and cross-functional review of compliance management system performance
• Manage the Halyard Compliance Audit Schedule and Risk Priority Matrix
• Coordinate annual compliance audit activities
• Ensure Compliance Management program meets regulatory requirements
• Assist in the development of computerized QS for Compliance Audit Management
• Develop and maintain Compliance Management procedures
• Develop and deploy meaningful compliance metrics
• Conduct evaluation of external regulatory trends and comparison with internal compliance results to determine actions needs in future compliance activities
• Develop and deliver training modules for Compliance Management
• Provide updates of Compliance Management activities to expedite innovation and risk mitigation in quality systems compliance
• Conduct compliance training activities with internal manufacturers as necessary
• Manage regulatory inspection audit database for internal facilities and oversee corrective actions submitted for external audits and inspections
• Maintain regulatory inspection database for notifications received from contract manufacturers and suppliers and evaluate potential risk for Halyard Health
• Act as Compliance advisor in critical/complex product and process system projects/
• Participate in FDA readiness activities and support FDA and External Audit process as necessary
• Participate in due diligence activities as required

Interested?  Please send your resume to d.beach@accenture.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.

 Qualifications

  • B.S. in Engineering, Science, Quality Systems or related field
  • Certification as CBA, CQA or ISO 13485 Lead Auditor (strongly recommend or to be obtained during the first 3 months in the position)
    • 7-10 years of Manufacturing, Quality Engineering, Compliance, Quality Systems or Regulatory Affairs experience in medical devices, pharmaceutical, biologics, or other highly regulated industry
    • 5-7 years of experience conducting gap assessment, risk analysis of complex failure investigations,internal/supplier or external audits; quality system remediation projects or similar compliance activities in quality systems for medical devices (this can include QS Management experience on Quality operations, coordination of quality engineering or quality systems activities, customer complaint handling, risk assessment or design control activities, supplier quality, etc.)
    • Experience as an Internal Auditor, Lead Auditor, Project Management coordinator or conduction complex gap assessments of manufacturing process or product related issues.
    • General Knowledge of 21CFR requirements
    • Knowledge of ISO standards like ISO 13485, ISO 9001, ISO 14971
    • General understanding of Sterilization and Environmental standards
    • Strong project management and failure investigation/root cause analysis skills (highly desired)
    • Strong technical skills expertise (product validation, process, validation, software validation, reliability, risk assessment, statistical techniques) (Highly desired)
    • Proven record of successfully working in a global environment
    • Due to the high interaction with Internal Halyard locations or the regions, a fully bilingual (English/Spanish) person is required
    • Excellent written and verbal communication skills
    • Excellent instruction/teaching skills

    Specialized Knowledge:
    • Masters in Engineering, Sciences or Statistics (highly desired)
    • 10 years relevant work experience in medical devices, pharmaceutical or biologics industry
    • Knowledge in 21 CFR 801, 803, 806; Part 11, CFR 58 and other FDA requirements
    • Knowledge in other regulations like JPAL Min. Ordinance 169, CMDCAS, MDD, NIOSH, ANVISA, etc.
    • Experience in deploying QS in a global environment
    • Experience in Supplier Evaluation activities
    • Medical device GxP & ISO Standards proficiency
    • Supplier/process/system validations proficiency
    • Risk assessment, Hazard Analysis, FMEA, QFD proficiency
    • Problem analysis proficiency
    • Statistical proficiency
    • Strong interpersonal skills
    • Leadership skills

 

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

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.

K-C hiring Maintenance & Reliability Opers Lean PM | Paris, TX

MAINTENANCE & RELIABILITY OPERATIONS LEAN PM -Paris, TX – job#11398

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. Kimberly-Clark’s global brands are sold in more than 150 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.

Position Summary:

This position is located in northeast Texas 98 miles from Dallas on the western edge of the Piney Woods and has a population of about 25,000.  Our Paris Mill received a 2009 Texas Environmental Excellence Award from the Governor and is our flagship facility for diaperes.  To maintain this recognition the incumbent may be responsible for the leadership/management of a multi-skilled technical team, a highly technically complex manufacturing process or a combination of functional. Responsibilities include project results, project control, the design, development, implementation, and optimization of asset care/reliability centered business processes.  Incumbent is a recognized leader in reliability systems and processes, possesses high standards of professional performance, and demonstrates both personal and organizational sensitivity.

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 #11398.  You can also directly apply for job #11398 at http://bit.ly/11398-MainOper after setting up a profile.

KEY CUSTOMERS:

Plant leadership team, maintenance, operations, and engineering teams, Staff Engineering, other functional team members and External Technical Consultants.

SCOPE:

The incumbent typically reports to Reliability Manager.   Assignments may vary from individual contribution to team leadership.

Significant time may be spent ”on the floor” with the incumbent in continuous contact with team members regarding production/maintenance reliability issues and processes.  The incumbent provides leadership in achieving team objectives.  This person may lead multi-functional teams assigned specific objectives.

QUALIFICATIONS/EDUCATION/EXPERIENCED REQUIRED:

-Requires knowledge and ability typically associated with a bachelor’s degree in technical/engineering field.

-Direct 8-10 years industrial experience in a high-speed manufacturing environment, and considerable knowledge and experience in operations/maintenance at the functional and leadership levels.

-Prior experience with Lean concepts, implementation, training and problem solving methodologies a must.

-Must have demonstrated familiarity with asset life cycle management concepts, a clear understanding of asset availability and capacity models, demonstrated development and implementation of predictive and preventative maintenance systems/processes and have worked in/on optimization teams focused on continuous improvement.

-Incumbent will have demonstrated the capability of facilitating projects/programs in a team environment while providing team leadership.  Making presentations within the team, planning work activities to meet deadlines, and coaching to enhance individual performance are typical experiences.

-Incumbent may have experience in more than one functional area.  The incumbent will have managed projects in an operations area or other functional area, will have participated in the development of department objectives and goals and action plans to achieve them, and will have worked in an environment where success was achieved equally through leading others and possessing technical knowledge.

Preferred qualifications:

•             Advanced technical degree

•             Certification(s) as a Maintenance and Reliability Professional  (CMRP), ISO or similar certification

•             Lean/Six Sigma certification(s)

•             Certification in Project Management

DIMENSIONS:

Vary widely with assignment and typically include:

•             Project responsibility of $1 MM to $10 MM

•             Project team of three to fifteen people

•             Single or multiple projects

Equal Opportunity Employer