Full Time
Engineering
Milwaukee, WI, US

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/inspe...