TEMP Senior Quality Engineer I (Supplier Development)

Position Overview:Quality Engineer has the primary responsibility of supporting the supplier development and manufacturing of components and parts for Class I, II and III medical devices. Commodities will include electronics, molding, electro-mechanical, as well as mechanical industries. This position supports the review of new/existing designs for component DfX impact at the upstream supply chain, onboards new suppliers to the ASL and establish sourcing links upon completion of parts qualification. This position also supports the Quality Engineering staff with the technical liaison activities between R&D, Supplier Quality, commercial operations staff and the supplier. This person will also support the supplier part qualification program. Responsibilities include review of and filing of PPAP documentation, transact sourcing link of parts to supplier based on completion and approved parts qualification. Additional work around initiating FAI forms for inspection and coordinating inspection work with QA operations. Support creation of inspection plans at supplier. The Quality Engineer will ensure all procedures and records meet regulatory and requirements.Responsibilities:• Support Quality Engineering, R&D and commercial engineering in the evaluation of new suppliers and components. • Support the engineering teams to assess technical and manufacturing capabilities of prospective suppliers and define necessary technical requirements, tests and documentation for sourced products. • Provide the product development teams with SME knowledge of manufacturing processes, such as PCBA manufacturing, OEM electro-mechanical assembly, machining/metal forming and plastics molding. • Support supplier validations. • Support execution of supplier qualifications including evaluation of supplier product realization processes to ensure suppliers can produce components that consistently meet pre-determined specifications. • Support MSA at supplier and work with Quality Engineers and Design/Manufacturing Engineering to ensure continuity of Product and Process Quality Control Plans with Receiving Inspection. • Investigate and disposition identified supplier related nonconforming components. • Support Supplier Change Notification program. o Evaluate supplier changes request and coordinate review with internal staff. o Collaborate with suppliers on internal specification changes. Supplier Quality • Ensures the supplier development and parts qualification process aligns with the Supplier Quality program. • Review the Approved Supplier List to ensure ASL data accuracy. • Supports Supplier Quality Engineering on routine supplier technical assessments/process assessments based on performance data. Support the issuance and closure of Supplier Corrective Action Requests (SCAR) and Supplier Notification (SN) process. • Review documentation to support changes at suppliers. • Work with suppliers to resolve quality issues. Other Duties as Assigned • Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives. Experience:• Bachelors degree in Engineering (Mechanical, Electrical, Industrial preferred) • 5 to 8 years work experience in a production or engineering environment required • Masters degree with 3 to 5 years work experience • 3-5 years in Medical Device or other semi-regulated industries required. • Aptitude towards most and mastery of some of the general knowledge, skills and abilities listed below. • Coach/provide guidance to other personnel • Technical process knowledge of plastics/polymer molding, alloy machining and forming, and electronics/electromechanical assembly. • Product/process validation experience • Strong knowledge of medical device manufacturing. • Knowledge of Process Capability and data analysis using statistical tools • Working understanding of 21 CFR Part 820 and ISO 13845 and 14971 requirements • Knowledge of FDA process validation • ASQ certifications preferred. CQA, CBA, CQE • Excellent documentation skills, attention to detail and accuracy • Team player, good written/oral communicator • Must be organized and able to coordinate activities with internal departments and outside suppliers. • Strength is working well in a team environment while continually and constructively challenging the status quo.

Created: 2025-10-02