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Quality Assurance Manager

3 months ago

Cambridge, United States SSi People Full time

Note: Open to the candidates who are either USC / GC / EAD a big no to C2C.

Job Title: Quality Assurance Manager - Hybrid

Location: Cambridge, MA

Pay Rate: $57/hr to $59/hr

Responsibilities:

  • The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Manage assigned projects to completion and provide quality oversight including review and approval of documents.
  • Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.

Required Skills:

  • Looking for validation, method, quality, and experience in medical device.
  • Project management experience.
  • Experience with medical devices Methods and equipment validation,

With over 20 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do, we have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.