Senior Quality Assurance Manager
We are looking for a Senior Quality Assurance Manager (Devices) to come and join a global Life Science client of ours based in Massachusetts.
In this position, you will be responsible for all aspects of QA for Medical Devices and Combination Products - manufactured onsite & at third-party manufacturers.
Responsibilities :
- Oversee Quality Management System and ensure compliant to FDA Part 4, Part 210 / 211, Part 820, ISO 13485, Canadian Regulations and EU MDR 2017 / 745
- Review and approve DHRs (Device History Records)
- Oversight and continuous improvements of QMS following FDA & ISO regulations
- Responses to Product Quality Complaints or Inquiries
- Oversight of Supplier / Vendor Management Programme
- Manage QMS (Trackwise)
- Review and approve SOPs related to Medical Device and assoc systems
You Need :
- Bachelor's Degree in related Scientific discipline
- Strong knowledge of Medical Device Regulations
- Lead a QA Function in Medical Device or Combination Products
- 8-10 years QA Experience in a manufacturing facility
- Experience in leading inspections by FDA and Health Canada
- Experience in leading internal and external audits
Generous relocation package offered!!
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