Senior Quality Engineer - Combination Product
Core
Ensure compliance with cGMP requirements for drug-device combination therapies and support manufacturing operations.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Drug-device combination product manufacturing lines
Domain
Medical device / Pharmaceutical manufacturing
Required skills
cGMP compliance, root cause analysis, statistical analysis, FMEA, quality audit execution, process monitoring, regulatory knowledge (21 CFR Part 4, 210, 211), Microsoft Excel, Minitab (via careerplan.io/jobs/563602809657751-senior-quality-engineer-combination-product-at-bostonscientific)
Preferred skills
Technical leadership, cross-functional project management, external regulatory audit experience
Technologies
Microsoft Excel, Minitab
Responsibilities
Lead compliance and continuous improvement initiatives for combination product manufacturing; Serve as technical quality lead during internal and external audits; Analyze quality data to identify trends and drive corrective actions; Develop quality tools, training materials, and product quality plans; Lead cross-functional teams to reduce manufacturing defects; Support product containment activities and release criteria documentation; Evaluate effectiveness of quality systems against regulations.
Seniority
Senior, hands-on IC