Senior Quality Manager - Medical Device in Boston at Apple & Associates

Date Posted: 9/2/2018

Job Snapshot

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Job Description

Our client, a leading manufacturer of innovative medical devices has a new opening for Senior Quality Systems Manager to join their team in the Boston area (North of Boston). The Senior Quality Manager will lead the quality function at the manufacturing site of 700 FTEs as well as lead many global counsels and have ultimate responsibility for two additional global locations in regards to complaints and CAPA and Audit resolutions.  Therefore, the ideal candidate will have some experience with global manufacturing sites. 

Senior Quality Systems Manager - Medical Device Responsibilities:
  • Provides leadership and oversight for the manufacturing site, a medical device components business, an extrusion business and some global oversight for specific products
  • Plans, develops and monitors the Quality Management System for all businesses, including FDA, ISO 13485, TUV and BSI.
  • Ensures that all quality objectives are met
  • Direct supervision of entire Quality Systems organization - over 30 indirect reports
  • Sees that Quality, Operational, Process Improvement, and Product Development & Transfer projects are implemented efficiently
  • Communicates with operations groups and customers to resolve any design issues or related product issues
Senior Quality Manager - Medical Device Requirements:
  • Bachelor's degree required, engineering, science, or technical required, Master's preferred
  • 7 or more years of experience in the Medical Device industry with strong quality system oversite, CAPA, Audit etc
  • 5-7 years of managerial or director level experience in a quality group with examples of mentorship and development of employees
  • ASQ Certification
  • Past experience with Medical Device Manufacturing Plant Quality oversite, including microbiology groups or sterilization is preferred
  • Six Sigma Black Belt or Lean training desired 
  • Good project management skills
  • Prior experience with product transfers/start-ups preferred
  • Ability to work well in a fast paced environment while managing multiple projects
Candidates near Boston preferred, but full relocation is available from anywhere in the USA.
Visa Sponsorship will be considered for current Visa holders.