Quality Assurance Engineer (Onsite - Acton, MA)
Core
Ensuring medical device manufacturing products and processes meet quality, safety, and regulatory requirements through root cause analysis, CAPA support, and process validation.
Role type
Quality Assurance Engineer (Medical Device Manufacturing)
Builds
Safe and effective medical devices via compliant manufacturing processes
Domain
Medical Device Manufacturing / Quality Engineering
Required skills
Root cause analysis, CAPA management, Process validation (IQ/OQ/PQ), Risk assessment (FMEA, ISO 14971), Statistical analysis (Minitab, SPC, DOE), Technical writing, FDA/ISO compliance knowledge
Preferred skills
ASQ CQE certification, Auditor training (ISO 13485), MDSAP audit support, Advanced Excel proficiency
Technologies
Minitab, Excel, FMEA tools, SPC software
Responsibilities
Investigate nonconformances and conduct root cause analyses, Develop and manage quality programs for manufacturing issues, Participate in Material Review Board for disposition decisions, Support process validations and write validation protocols/reports, Assist or lead CAPAs and corrective actions, Support internal and external audits and regulatory inspections
Seniority
Mid-level, hands-on IC