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Quality Engineer
MPE
Milwaukee, USA
Full-time
Entry · 0+ years experience
Onsite
Discovered 1 weeks ago
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Role Overview
Under the supervision of the Regulatory and Quality Systems Manager, the Quality Engineer is a development-oriented role intended to build capability across both new product development/design transfer and site quality/sustaining production. The position will partner with Engineering, Operations, Supplier Quality, Quality Systems, and other cross-functional groups to support compliant product launch, production readiness, and ongoing manufacturing quality. Primary assignments may emphasize the NPD/design transfer path or the site quality path based on business needs, individual skill set, and capacity requirements.
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Job Summary
Under the supervision of the Regulatory and Quality Systems Manager, the Quality Engineer is a development-oriented role intended to build capability across both new product development/design transfer and site quality/sustaining production. The position will partner with Engineering, Operations, Supplier Quality, Quality Systems, and other cross-functional groups to support compliant product launch, production readiness, and ongoing manufacturing quality. Primary assignments may emphasize the NPD/design transfer path or the site quality path based on business needs, individual skill set, and capacity requirements.
Essential duties and responsibilities
- Ensure assigned quality engineering activities comply with ISO 13485, applicable FDA/QMS requirements, customer requirements, and MPE quality system procedures.
- Review drawings, specifications, BOMs, work instructions, test/inspection criteria, labeling, packaging, and other quality records for manufacturability, control, and objective evidence needs.
- Support transfer and production readiness activities, including FMEA, CTQs, control plans, inspection strategy, PPAP, qualification/validation planning, and production readiness reviews.
- Apply statistical tools to sampling plans, measurement systems (GR&R), process capability, test planning, and data review as appropriate.
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