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QUALITY ENGINEER – QMS
Ref No.: 19-11232
Location: Neenah, Wisconsin
Our client, a leading fortune company is looking for a QUALITY ENGINEER. This is for an initial duration of 6 months and is located in Neenah, WI

Job Description:

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.

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 Client 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.

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 Client 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


Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.