Quality Assurance Manager

1 week ago


Marlborough, United States BioTalent Full time

BioTalent is partnered with a family-run medical device component manufacturer looking for their next Quality Assurance Manager They need someone with direct plastic injection molding experience who can step in immediately.


Education: Bachelor’s degree in a relevant engineering discipline.

Experience: Proven experience in quality assurance, ideally at a Senior Engineer or Manager level within the plastic injection molding industry or a related field.

Technical Knowledge: Strong understanding of quality standards, regulations, and best practices specific to manufacturing. Familiarity with ISO 13485 or similar quality management systems is required.

Required Skills:

  • Established experience with plastic injection molding, ideally in the medical device industry.
  • Experience with daily quality initiatives including: lead audit experience, CAPA management, QMS management, root cause analysis, team leadership.
  • The ideal candidate has experience managing/working on the shop floor.
  • Proficiency with quality management software and tools.

Certifications: ASQ certification, such as Certified Quality Manager or Certified Quality Engineer, is a plus.

Leadership: Excellent communication and leadership abilities to train, supervise, and motivate inspectors, quality technicians, and engineers.

Collaboration: Team-oriented approach with strong cross-functional collaboration skills.



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