Head of Quality Assurance

2 weeks ago


Billerica, Massachusetts, United States Wimmer Solutions Full time
Head of QA Job Description

Wimmer Solutions is seeking a highly skilled Head of QA to lead our Quality Assurance team in ensuring the highest standards of quality and compliance in our medical device manufacturing processes.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements, including FDA Part 4, Part 210/211, Part 820, ISO 13485, and EU Medical Device Regulation 2017/745.
  • Lead QA medical device and combination products compliance and auditing operations, making sound decisions regarding evaluation of cGMP compliance.
  • Collaborate with cross-functional teams to ensure site readiness for regulatory agency inspections and corporate audits.
  • Develop and deploy modern root cause and problem-solving techniques, such as statistical process controls and quality function deployment.
  • Ensure excellent understanding of medical device QA principles, industry practices, and standards.

Requirements:

  • Bachelor's degree in Science or related scientific fields.
  • Strong knowledge of medical device regulations, including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), and CMDR (SOR/98-282).
  • Experience in working directly with FDA.
  • Demonstrated leadership ability and sound decision-making skills.
  • Excellent communication and problem-solving skills.

What We Offer:

  • Salary range: $120k to $140k based on experience and qualifications.
  • +10% bonus.
  • 3 weeks paid vacation.
  • 401(k) match.

Language: English



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