Supplier Quality Engineer II

Supplier QA Eng - P2 (Supplier Quality Engineer II)
Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.
ResponsibilitiesAssess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.Develops and/or sources inspection tools and equipment.Assists in generating component specifications.Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.Reviews new design specifications and provides input from component quality and manufacturability perspective.Investigate field failures related to supplier materials. Develop corrective action plan where necessary.May supervise inspectors.
Requirements:BS degree in engineering with a minimum of 3 years of related experience or an equivalent combination of education and work experience. Experience in medical devices or other regulated industry. Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing. Experience in process validation, design controls, risk management, CAPAAbility to work independently; organized and self-driven. Articulate communicator; adept at packaging and appropriately scaling information to the intended audience. Problem Solving and Project Management experience
ASQ certification (CQE, CBA, SSGB, SSBB) desired. Experience managing supplier quality issues, including supplier nonconformance escalation and SCAR ownership.Experience monitoring supplier performance and supporting continuous improvement activities.Experience supporting component qualification and supplier process changes.Fully Bilingual