Senior Quality Assurance Leader

2 weeks ago


Cambridge, Massachusetts, United States SSi People Full time

Note: Open to candidates who are either USC / GC / EAD; C2C applications will not be considered.

Position: Quality Assurance Manager - Hybrid Role

Compensation: $57/hr to $59/hr

Key Responsibilities:

  • The Quality Assurance Manager will oversee quality documentation including Deviations, CAPAs, and Change Controls, along with the review and approval of testing method documents.
  • Experience in generating material and testing specifications, writing protocols and reports, and developing processes and tests, including prototyping and design verification/validation.
  • Involvement in product design and development from initial concept through to post-launch for both European (EMEA/CE Mark) and US (FDA/PMA/510k) submissions.
  • Manage projects to completion while ensuring quality oversight, including the review and approval of relevant documents.
  • Experience in designing and developing testing or inspection methods, particularly in small-scale device assembly or benchtop testing.

Essential Skills:

  • Validation, method development, quality assurance, and experience in the medical device sector.
  • Project management capabilities.
  • Familiarity with medical device methods and equipment validation.

With over 20 years of industry expertise, SSi People is dedicated to prioritizing people. Our approach is centered on delivering exceptional experiences for our consultants, clients, and internal teams. Through a genuine commitment to people, we have refined our processes and built a stellar internal team to deliver talent efficiently. We emphasize the importance of fostering long-term relationships over mere transactions, embodying our philosophy of putting people first.



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