Supplier Quality Engineer II

Requirements

• Bachelor's degree in engineering, Physical Science, or related discipline.
• 5+ years' Supplier Quality experience in a medical device company
• Minimum of 5 years' experience executing New Product Development, Design Controls, and/or developing Design Control Processes in accordance with CFR 820.30 (FDA QSR) and/or ISO 13485.
• Experience working with class III medical devices.
• Working knowledge of ISO 13485, 14971 and FDA CFR 820 and similar global standards.
• Thorough understanding

Benefits

Additional Information

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. The Supplier Quality Engineer II provides technical supplier management leadership supporting the development, commercialization, and on-going supplier relationships to support an implantable medical device system. This position will be a key stakeholder to ensure robustness in supplier selection, supplier qualification, component qualification, supplier corrective actions and participate in the development of various supply chain strategies. Working cross-functionally with Engineering, Operations, Supply Chain, and external contract manufacturers and suppliers, this role ensures supplier quality systems, component quality, and regulatory compliance are established and sustained. The Supplier Quality Engineer will define and execute technical purchasing control requirements through consultation, critical review, and hands-on ownership of supplier quality deliverables. At Anteris Technologies, you will be part of a team dedicated to improving the quality of life for patients with aortic stenosis through innovative, life-changing medical devices. In this role, you will: Execute the supplier and component qualification processes. Lead the supplier management activities, including supplier audits, scorecards, corrective action and change management. Lead the investigation, permanent resolution, and prevention of supplier component nonconformances. Review component specifications and proposes changes to existing specifications to support component quality and manufacturability. Manage development of supplied product inspection procedures, internally and at suppliers, and first article requirements. Provide engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, and Gage R&R studies. Assess supplier capabilities through direct visits, technical discussions, and directed testing. Collaborate with suppliers to develop comprehensive process validation strategies. Proactively communicate quality issues to suppliers as needed through supplier corrective action requests, data driven and technical discussions. Drive the development, maintenance, and improvement of quality of components sourced from outside suppliers. Responsible for contract manufacture's performance and evaluation. Evaluate and develop control plans, skip lot, dock-to-stock, CoC, and CoA partnerships with suppliers. Apply thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies and data gathered. Work with Manufacturing Engineering to assess and address supplied component issues. Responsible for Supplier Quality activities such as: Supplier Audits, Supplier performance, etc. Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member). Mitigate risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans. Support internal and external audits - including preparation and direct interaction with auditors. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Perform other related duties and responsibilities, on occasion, as assigned.

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