Supplier Quality Engineer
Core
Support supplier selection, qualification, and management to ensure product/service quality meets Insulet requirements; manage design control initiatives to ensure current and new medical device projects meet regulatory and quality requirements.
Role type
Supplier Quality Engineer / Design Control Engineer
Builds
Medical device products (OmniPod platform)
Domain
Medical Devices / Quality Management Systems
Required skills
Supplier qualification, Supplier audits, CAPA management, Design control documentation, Risk management, Regulatory compliance (FDA/ISO), Data analysis, Project coordination
Preferred skills
Auditor training certification (ISO 13485/17025), Experience with EN 60601 and ISO 62304, Phase-gate process familiarity
Technologies
Microsoft Office (Word, Excel, PowerPoint, Access), QMS software
Responsibilities
Maintain approved supplier list and audit schedules; Conduct supplier audits and prepare reports; Develop and execute qualification plans for new suppliers/components; Manage CAPA for audit deficiencies and non-conformances; Generate supplier performance reports and scorecards; Review and approve Design Control documents and protocols; Support Risk Management activities; Assist with internal and external audits (BSI, FDA, Customer).
Seniority
Mid-level, hands-on IC