Quality Systems Manager
Anteris TechnologiesMinnesota, United States
Posted January 20, 2026
125000 - 135000 USD
Full Time
About the Company
Anteris Technologies is a global structural heart company that develops science-driven solutions to restore healthy heart valve function. The firm’s flagship product, the DurAVR® transcatheter aortic valve (THV), is the world’s first biomimetic TAVR valve, engineered with proprietary ADAPT® anti-calcification technology to replicate natural valve dynamics. Anteris targets younger, active patients who require durable, physiologic valve replacement beyond the traditional high-risk cohort. By combining advanced biomimicry with measurable performance metrics, the company positions itself at the forefront of next-generation cardiac care.
Job Description
As the Quality Systems Manager at Anteris, you will play a key leadership role supporting our mission to deliver safe, effective, and high-performing medical devices. Reporting to the VP of Quality, you will manage the day-to-day implementation, execution, and continuous improvement of Anteris’ Quality Management System (QMS), with an emphasis on CAPA, Document Management, Change Control, QMS Training, and QMS IT systems.
Requirements
- 5+ years of progressive quality experience within the medical device, biotech, or regulated healthcare industry.
- Demonstrated experience leading and improving quality system processes such as CAPA, document control, training, change control, and internal audits.
- Strong working knowledge of applicable regulations and standards including 21 CFR 820, ISO 13485, ISO 14971, and EU MDR.
Benefits
- Medical, Dental, and Vision Plans
- Flexible Spending Account (FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
- Paid Holidays & Vacation
- Employee Assistance Program
