Supplier Quality Engineer to implement and execute quality plans to monitor and improve the supply chain, ensuring quality components that meet specifications. Establish QMS and regulatory requirements in conjunction with Supply Chain with assigned suppliers. Perform or manage on-site supplier audits. Participates in supplier’s design review, product validation, design verification, Risk Management plans/reports (dFMEA, pFMEA). Develop and maintain metrics to trend and report supply chain quality issues, and use them to launch timely response, as required, or provide information so that is can be sent. Will be involved in supplier quality activities, including both troubleshooting/CAPA and continuous improvement initiatives. Recommend and implement supplier improvement plans. Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis. Manage supplier corrective action requests to closure, and train internal team members on SCAR requirements. Support development of incoming product strategy and investigation and disposition of nonconforming materials. Serve as Quality Representative on MRB.
- Bachelor’s Degree in Engineering or technical discipline.
- 3+ years of Quality Assurance experience in a regulated manufacturing environment, with at least 5 years in medical device manufacturing.
*U.S. Citizen or Green Card Holder Required.