Quality Engineer II - Delivery System
External
Anteris Technologies · Maple Grove, MNPrepare for this interview
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Requirements
- Bachelor's degree in Engineering, Physical Science, or related discipline
- 2+ years of manufacturing quality experience in a medical device company
- Experience supporting process validation, risk management, nonconformance handling, and process improvement in regulated environments
- Working knowledge of FDA CFR 820, ISO 13485, and ISO 14971
- Understanding of process controls, statistics, test method validation, and new product development processes
- Experience with product and process verification and validation activities
- Strong technical writing and documentation skills
- Master's degree in Engineering or related field
- Experience with Class III medical devices
- Experience with valve manufacturing or biological tissue products
- Familiarity with ISO 5840 standards
- Strong knowledge of inspection methods and measurement systems
- Experience with statistical tools, DOE, and process capability analysis
- Certifications such as ASQ CQE, Six Sigma, or CQA
- Experience with requirements management tools (e.g., Jama Connect)
- Demonstrated ability to solve complex problems and contribute in a fast-paced, cross-functional environment
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. Anteris Technologies is seeking a Quality Engineer II to support the development, commercialization, and ongoing manufacturing of our delivery system. In this role, you will be a key contributor to ensuring manufacturing quality, process robustness, and regulatory compliance across our product platform. You will work cross-functionally with engineering, manufacturing, and quality teams to drive validation, risk management, and continuous improvement initiatives. In this role, you will: Partner with R&D, Design, Process, and Manufacturing Engineering to develop and execute product and process validation strategies. Support delivery system manufacturing processes, including product quality activities. Participate in cross-functional mRB discussions and support nonconformance invesigations, including CAPAs and customer complaints. Develop sampling plans and approve inspection methods for in-process and finished product acceptance. Review and support execution of validation activities including IQ, OQ, PQ, TMV, and software validation Analyze product and process performance to identify failure modes, trends, and opportunities for improvement Support resolution of complex technical issues related to manufacturing processes Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution Maintain and assess effectiveness of CAPAs and quality system processes Contribute to risk management activities, including PFMEAs and process risk assessments Develop and maintain process monitoring and control strategies aligned to product and process risk Evaluate process variation and capability, driving continuous improvement initiatives where needed Support development and maintenance of quality documentation, including control plans, work instructions, and inspection methods Participate in internal and external audits and respond to audit observations as needed Conduct manufacturing process audits to ensure adherence to GMP, production controls, and quality standards
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