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Validation Engineer

2 months ago

Cambridge, United States SSi People Full time

Title: Equipment Validation Engineer/ Quality Assurance Manager

Location: Cambridge, MA (Hybrid)


Skills:

Project Management, experience with medical devices Methods and equipment validation, Quality mindset


Responsibilities:

Manage assigned projects to completion and provide quality oversight including review and approval of documents.

  • 8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
  • 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.