Sr Quality Assurance Engineer (Onsite - Acton,MA)
Core
Ensuring quality, safety, and regulatory compliance of medical device manufacturing processes while serving as a key quality representative for production operations.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Safe and effective medical devices (Insulin Management Systems)
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 (SPC, Cpk, DOE), Regulatory compliance (FDA, ISO 13485), Technical writing
Preferred skills
ASQ CQE certification, Auditor training (ISO 13485), Minitab/Excel proficiency, FDA inspection support experience
Technologies
Minitab, Excel, FMEA, IQ/OQ/PQ, SPC, DOE
Responsibilities
Lead root cause investigations for nonconformances, Manage CAPAs and corrective actions, Support process validations and audits, Mentor junior engineers, Review manufacturing documentation and protocols, Participate in Material Review Board
Seniority
Senior, hands-on IC with mentorship duties