Supplier Quality Engineer, Plastics (Onsite - Acton, MA)
Core
Ensuring supplier governance and quality systems for medical device manufacturing, specifically focusing on plastics sourcing and production continuity.
Role type
Supplier Quality Engineer (Plastics)
Builds
Medical device components (Plastics category) for Insulet's Omnipod product platform
Domain
Medical Devices / Plastics Manufacturing
Required skills
Plastic injection molding, mold tool design, material selection, DFM, PPAP, DOE, process capability analysis, Gage R&R, control plan, SPC, root cause analysis, QMS audits, 21 CFR Part 820 compliance
Preferred skills
Plastics manufacturing experience, sub-tier supplier management
Technologies
SPC, Gage R&R, Control Plan, PPAP, SCAR
Responsibilities
Develop and monitor KPIs and dashboards for supplier quality metrics; Lead supplier selection and performance improvement initiatives; Drive root cause analysis and corrective actions for non-conforming products; Coordinate technical assessments for supplier change requests; Interface with cross-functional teams and external suppliers on quality issues.
Seniority
Junior to Mid-level, hands-on IC