Sr. Supplier Quality Engineer - Metals (Onsite - Acton, MA)
Core
Managing and improving supplier quality for metal components used in medical devices, ensuring products meet quality and regulatory requirements.
Role type
Senior Supplier Quality Engineer (SQE)
Builds
Medical device components (metals)
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality engineering, metals manufacturing (stamping/spring forming), QMS systems, regulatory compliance (21 CFR Part 820/11), root cause analysis, supplier performance monitoring, process validation, audit management, KPI development, dashboard creation, PPAP, DOE, process capability analysis, Gage R&R, control plan, SPC, inspection procedure development
Preferred skills
Metals manufacturing or materials experience
Technologies
None explicitly stated
Responsibilities
Develop and monitor KPIs and dashboards to track supplier quality system health; Lead root cause analysis and corrective actions for non-conforming products; Engage with suppliers and SCM to drive performance and accountability; Coordinate technical assessments for supplier change requests; Support supplier selection and production part approval processes; Collaborate with cross-functional teams on quality management systems and audits.
Seniority
Senior, hands-on IC
