Sr. Quality Engineer
Katalyst Healthcares and Life SciencesBoston, MA, United States9 days ago
Job type
- Full-time
Job descriptionM.S. in Engineering with 3+ years, or B.S. with 5+ years of experience. 2-5 years in a regulated medical device environment; experience with combination products preferred. Knowledge of ISO 13485, ISO 14971, 21 CFR 820, and cGxP principles. Experience with DHF management, risk management, and lifecycle management. Strong statistical, technical writing, and communication skills. bility to work independently, manage multiple projects, and collaborate effectively with cross-functional teams.
Responsibilities :
- Ensure design control compliance and maintain Design History Files (DHF) for new product development.
- Review and approve design documentation, risk analyses (dFMEA, uFMEA, pFMEA), and verification / validation protocols.
- Support change control, impact assessments, and DHF updates.
- Investigate product complaints, lead root cause analyses, and support corrective actions.
- Evaluate product designs for manufacturability, reliability, biocompatibility, and compliance.
- Contribute to new product commercialization and continuous improvement initiatives.
- Support vendor management, audits, and documentation for product release.
Requirements :
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Sr Quality Engineer • Boston, MA, United States
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