- Experience with medical device qualification processes (IQ OQ, PQ)
- Experience in medical device product development, including key project milestones like Design Verification and Qualification timing
- Familiarity with US FDA regulatory requirements
- Understanding of product design and manufacturing processes for medical devices such as injection molding, assembly, extrusion, and braiding
- Collaborates with internal and external project teams to carry out medium complexity project tasks, providing regular updates to stakeholders
- Supervises buyer/planners regarding purchase order needs and specifications
- Identifies, evaluates, and selects suppliers independently
- Negotiates payment, pricing, and delivery terms for project components with minimal supervision
- Monitors suppliers' quality, delivery, and overall performance within the project
- Proficiency in Microsoft Project and Excel
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Supplier Quality Engineer - Houston, United States - LanceSoft, Inc.
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Description
Position: Engineering Project Manager/Supplier Quality Engineer
Location: Plymouth, MN – 55442
Duration: 5-Month Project; until the end of this year
Project Duration: Medium-term (1-2 years)
Function Engagement: Medium complexity (4 — 6 functions, single site)
Experience Level: 5-7 years overall experience, with a minimum of 3-5 years with a Master's degree
Job Description & Requirements