Job Title: Medical Device Supplier Quality Engineer
Location: Waukesha, WI
Type: Contract (11 Months)
Rate: $40/hour
We are seeking a skilled Supplier Quality Engineer with a strong background in medical devices to support supplier transfer projects and ensure compliance with regulatory standards. The role requires hands-on experience in design change management, supplier collaboration, and quality verification processes.
Key ResponsibilitiesDevelop qualification plans for supplier transfer projects and perform associated verification testing.
Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
Collaborate with engineering and cross-functional teams to ensure seamless project execution.
Compile design packages including drawings, specifications, and Bill of Materials (BOM).
Work directly with suppliers to clarify requirements and address technical inquiries.
Drive design changes to add or update approved suppliers.
Conduct verification of transferred items and manage First Article Inspections (FAIRs).
Partner with modality engineers to assess scope and impact of supplier transfers.
Degree in Electrical or Mechanical Engineering (a mix of both disciplines preferred).
Strong understanding of Medical Device Quality Management Systems (QMS) and related processes.
Proven experience managing end-to-end design change projects.
Electrical engineering background with knowledge of medical device standards (preferred).
Experience with design change activities: inputs, requirements, verification, and transfer.
Ability to read and interpret engineering specifications, technical drawings, and BOMs.