Engineering Manager- Supplier Quality

Job description

Support the Aortic and Peripheral Business Unit by providing hands on technical management responsible for leading a group of component and supplier engineers in selecting new product and service providers, characterizing, and qualifying new components for use in a wide range of Aortic & Peripheral medical devices; provide tactical implementation of long term supplier quality strategy, and developing, implementing, enhancement of supplier controls Quality Systems processes as it pertains to new product and service providers; coach, mentor, and challenge engineers within the group on all technical aspects of their respective jobs; develop and implement systems and processes for supplier management that are in compliance with FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485:2003; provide management and oversight of team regarding compliance of purchasing and supplier controls procedures; utilize DRM for device quality and reliability; oversee plastics commodities of injection molding, extrusion, and over-molding; implement new Business Group, Corporate or external (FDA, TuV and KEMA) quality and compliance programs; utilize CAPA (Corrective and Preventative Action plans); drive quality innovation through certification with a CQE, CRM, CQM or Six Sigma Black Belt certifications; manage supplier performance – audit Quality business review and technical visits to support development and sustainability of received product and service quality. Domestic and international travel required (25%).

Desired profile

Master's degree in Mechanical, Industrial or Manufacturing Engineering and three years of experience with component or supplier quality engineering in the medical device industry. Must possess at least three years of experience with the following: supplier management compliance to FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS and CMDR; plastics commodities of injection molding, extrusion, over-molding, and laser cut stents, electrical and electronic assemblies; supplier CAPA (Corrective and Preventative Action plans), NCMR (Non-conforming material) and SCC ( Supplier change control ) management; Class III medical device ISO 13485:2003 and FDA CFR 820; utilizing quality and compliance programs; supporting supplier related projects in partnership with cross functional team; DRM (Design for Reliability and Manufacturing) techniques; and serving as a Lead auditor. Domestic and international travel required (25%)