Tag Archives: process engineer

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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Halyard Health hiring Sr. Process Development Engineer | CA

Halyard logo

Title: Senior Process Development Engineer

Company: Halyard Health Corporation, NYSE: HYH

Job# 150001HX

Location: Irvine CA

Function: Manufacturing Operations

Reports to: Manager R&D

Summary:

The incumbent will report to the Manager of Advanced Process Development R&D responsible for the medical devices business. The incumbent will be responsible for design, development, and commercialization of processes and equipment for existing products and other new medical devices. They will work with project teams and leaders to create/redefine product specifications through innovative and robust processing solutions. The incumbent will also be responsible for test development, protocols and reports related to verification and validation device testing. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States.  Responsibilities:

  • Provide technical leadership on new medical devices, by designing and developing manufacturing processes and related fixtures and tooling that are consistent with low defect levels and low product cost.
  • Be the subject matter expert (SME) on any given project, and act as project lead to provide updates when the project leader is unavailable.
  • Conferring with vendors in determining product specifications and arranging equipment, parts, or material purchase, and evaluating products according to quality standards and specifications.
  • Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.
  • Working closely with the local manufacturing department to develop, coordinate, and implement technical training for employees.
  • Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&E and quality assurance functions.
  • Supporting company policies and procedures, goals and objectives, FDA regulations, and goods manufacturing practices.
  • Research and purchase new manufacturing technology, work in collaboration with the local engineering department to better production equipment functionality.
  • Implement the transition of new technology to make sure production continues successfully without any delays.
  • Act as a mentor to junior engineers within the Process Development Group.

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.

Basic Qualifications:

 

  • Bachelor’s Degree or advanced degree in Industrial, Manufacturing, Mechanical or Electrical Engineering.
  • A minimum of 10+ years’ experience in a variety of technical and/or operational assignments.
  • Strong experience using manufacturing analysis tools; such as but not limited to, DOE, process capability studies, six sigma etc.
  • Familiar with writing validation protocols, execution and thereafter data analysis.
  • Performed design transfers of new products from initial concept through launch.
  • Experience with working with external service providers.
  • Knowledge of engineering principles, scientific analysis, and project management.
  • Must be a good communicator-written and verbal.
  • A second language-Spanish would be an advantage.
  • Comfortable with giving technical presentations within and outside of Halyard Health.
  • Ability to prioritize multiple projects.
  • Must be able to work in a team environment and meet deadlines.
  • Willing to travel.

 

Additional Preferred Qualifications:

  • Master’s Degree in Engineering.
  • Experience in medical device manufacturing assembly processes including but not limited to-PU balloon forming, RF tipping equipment, Pad printing, UV/Thermal adhesive dispensers, vision systems and leak testing equipment.
  • Knowledge of polymer processing techniques.
  • Strong knowledge and background in mechanical engineering, with a strong ability to translate that knowledge into execution of process capabilities in major projects.
  • Green Belt in Lean Principles-Black Belt a Plus.
  • Ability to grasp modern technologies quickly.
  • Working knowledge of solid modeling (Solid Works preferred).
  • Working knowledge of Microsoft application-Word, Excel, PowerPoint etc.

 

 

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. 

 

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, sexual orientation, gender identity or any other characteristic protected by law.

 

 

Engineers – Did you ever Interview online before you talked to a recruiter?

KC-Unleash

Kimberly-Clark Corporation, a 147 year old global company, whose products you have used in everyday life, is trying out this method of rapid recruitment.  In using this tool by HireVue ALL applicants get to answer the same questions at a convenient time and place for them.  It’s called “On Demand Interview”, a simple online process and you would need Adobe Flash Player on your computer (download free from adobe.com), a webcam and a microphone.

You should watch the tutorial video first but if you opt out there is a practice question to get you started – 30 seconds to read the question and formulate an answer and three minutes to answer.  I recommend you review your answer!  There is a settings button to adjust volume, switch webcams or microphones.  Some suggestions:

  • Have good lighting in front of you
  • Dress for success as you would in a face-to-face interview
  • Do the practice question so you understand how you sound and look

 After completing the six questions that tell your story the video interview will go to a recruiter’s mailbox.  We have a Recruiting Team Lead that reviews all interviews and can start the application process.

To start – click one of these links.  Each one has questions specific to your discipline.

Kimberly-Clark #Hiring Mechanical Engineers— You can interview RIGHT NOW by clicking on this link: http://bit.ly/ME-interview  via HireVue

Kimberly-Clark #Hiring Process Engineers— You can interview RIGHT NOW by clicking on this link:http://bit.ly/ProcEngr-Interview via HireVue

Kimberly-Clark #Hiring Electrical Engineers— You can interview RIGHT NOW by clicking on this link: http://bit.ly/EE-Interview via HireVue

HireVue has 24×7 technical support if you have problems so what are you waiting for?