SR. Quality Engineer - Lean/Six Sigma --- Medical Device

Neenah, WI

Posted: 08/08/2019 Employment Type: Right to Hire Job Industry: Manufacturing Job Number: 19-01810


NO SUBCONTRACT REQUIREMENT:
No third-party applicants will be considered. If you are a third party contracting company, please do not respond to this position.

QUALITY ENGINEER – QMS



Position Purpose:
Provides high level Quality/Regulatory leadership for assigned quality systems, improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to all customers/stakeholders.


Customers:
Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Planning, Procurement, Legal, Marketing, Communications, Plants, Contract Manufacturers, Regulatory Agencies, Consultants.


General Expectations and Accountabilities:
  • Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
  • Manages self and/or team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
  • Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
  • Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
  • Performs production and quality systems audits.
  • Develops and implements support systems and processes for managing quality records and documents that meet both internal and external requirements.
  • Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.
  • Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
  • Executes continuous improvement activities for established processes and initiates development of new processes.
  • Builds and maintains capability in Client QMS, Standards, and Regulations (FDA, Health Canada) to support objectives.

    Position Specific Accountabilities:
  • Act as the system owner of one or more critical/high-risk quality systems (CAPA/QNC, Internal Audits, Audit Readiness), making decisions on changes to standards, auditing system users (including Quality, R&E, Mills, and other enterprise functions) for compliance to standards, training users on the standards, and supporting targeted implementation as needed to deliver business results.
  • Identifies need for, develops, and executes continuous improvement plans for the assigned systems.
  • Builds and maintains capability within the assigned systems for compliance with QMS, Industry Standards, and Regulations.
  • Initiates and executes continuous improvement activities for established processes, and supports development of new processes.
  • Provides Quality System technical expertise and/or support to business, suppliers and other functional teams.
  • Assists in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives.
  • Initiates and follows up on CAPA and QNC related to the assigned systems.
  • Scope:
    This position reports to Sr. Quality Manager. Has responsibility for assigned customers as well as assisting with other customers. Assists in or leads moderate to large sized projects. Plans and carries out customer service and project responsibilities with minimal direction but asks for assistance/guidance when appropriate.
  • Qualifications/Education/Experience Required:
  • Normally requires a bachelor' s degree in science, engineering or related discipline and 8+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function. Experience should include close working relationships with customer functions, good breadth of knowledge of applicable FDA, Health Canada, and QMS requirements for formulated cosmetics and medical devices, technical quality skills in the applicable or related system area, demonstrated application of LEAN/ Continuous Improvement skills, and demonstrated skill as a trainer. Requires prior leadership experience with moderate to large sized projects or systems.

    Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification is preferred.

    Strong analytical skills including trend and statistical analysis.




    Travel Expectations:
    Position may require travel of up to 20% to support business requirements

John Simmons
Director of Business Development

John is currently the Director of Business Development for Contract Professionals, Inc. He currently manages the Green Bay, Wisconsin office and works with clients in Wisconsin, as well as several clients located throughout the United States.

John started his career in talent acquisition in 1998 in Boston, Massachusetts. For the past 20 years, John has worked with clients throughout the U.S. providing contingent and permanent staffing solutions in the areas of engineering, information technology and government/defense related positions.

John works directly with hiring managers and corporate recruiters to understand their staffing goals and future needs, in order to support their hiring initiatives.

In his free time, John enjoys golfing and spending time with his family and their dog “Inky."

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