Quality Systems Manager

Anteris Tech•Maple Grove, MN

20d

About The Position

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. 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. This role requires a hands-on, detail-oriented quality systems leader who can drive compliance and operational excellence in a fast-paced, global medical device environment, supporting readiness for Notified Body audits and FDA inspections, while strengthening scalable processes that support product development and manufacturing. At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Requirements

Bachelor’s degree, preferably in a scientific, engineering, technical, or related discipline.
Minimum 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.
Experience supporting external audits and inspections, including preparing teams, managing documentation, and responding to findings.
Experience managing and mentoring a team
Strong analytical skills with the ability to trend data, identify systemic issues, and implement sustainable improvements.
Excellent communication and collaboration skills, with the ability to influence cross-functional partners and drive execution.
Ability to work without visa sponsorship of any kind

Nice To Haves

Experience supporting implantable Class III devices and/or complex combination device systems.
Experience with TAVR and/or tissue valve manufacturing environments.
Experience working in a global organization and supporting multi-site QMS execution.
Experience working with electronic QMS tools (eQMS platforms) and driving system adoption and workflow improvements.