Manufacturing quality engineering

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. 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. 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 ongoing supplier relationships to support an implantable medical device system. 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.

Lead the investigation, permanent resolution, and prevention of supplier component nonconformances.

Review component specifications and propose 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.

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.

Be responsible for contract manufacturer’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 judgment to reduce the need for inspection in accordance with program policies and data gathered.

Work with Manufacturing Engineering to assess and address supplied component issues.

Be 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 working in partnership with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.

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.

Bachelor’s degree in engineering, Physical Science, or related discipline.

5+ years’s Supplier Quality experience in a medical device company.

Experience working with Class III medical devices.

Thorough understanding of design controls, risk management, statistics, test method validation, and new product development processes.

Proficient in technical report writing and review.

Structured and methodical problem‑solving approach.

Ability to travel approximately 15%.

Advanced knowledge of statistics, DOE, and process capability analysis.

Experience authoring documentation for regulatory agency review.

Target base salary range: $100,000 - $120,000, plus eligibility for an annual short‑term incentive (STI) targeted at 7% of base salary and equity participation. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) Competitive compensation package, including salary, performance‑based bonuses, and stock options.

Medical, Dental, and Vision Offerings

Flexible Spending Account (FSA)

Life, AD&D, Short‑Term and Long‑Term Disability Insurance

Bonus Plan Eligibility

Employee Equity Program

Paid Holidays

Employee Assistance Program

Note: We may require proof of COVID‑19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

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