Quality Systems Manager
Listed on 2026-02-07
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Healthcare
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Quality Assurance - QA/QC
Data Analyst
Overview
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.
Primary Duties and Responsibilities- Lead, maintain, and continually improve the Anteris QMS in accordance with 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and other applicable global regulations and standards.
- Serve as a key quality systems partner to cross-functional stakeholders including R&D, Manufacturing, Quality Engineering, Regulatory, Supply Chain, Clinical, and Operations.
- Ensure QMS processes are implemented consistently, remain inspection-ready, and scale effectively with organizational growth.
- Support quality system harmonization across global locations, ensuring consistent expectations and execution.
- Own and continuously improve the Corrective and Preventive Action (CAPA) program, ensuring timely initiation, strong root cause analysis, and effective corrective/preventive action planning.
- Lead the CAPA Board, facilitating prioritization, decision-making, and escalation of quality issues as needed.
- Ensure CAPAs are appropriately risk-based, well documented, and include verification of effectiveness to prevent recurrence.
- Track and communicate CAPA performance trends, aging, and effectiveness metrics to leadership.
- Provide leadership and oversight to the Document Control and Training Specialist, ensuring effective execution of document lifecycle management and training compliance.
- Ensure controlled documents (policies, procedures, work instructions, forms, templates) are current, compliant, and accessible to end users.
- Ensure training programs support role-based competence and maintain compliance with required training assignments and completion.
- Drive improvements to document and training workflows to increase usability, reduce cycle time, and strengthen compliance.
- Lead and maintain the Change Control process to ensure changes are properly assessed, reviewed, approved, and implemented with appropriate risk-based rigor.
- Partner with cross-functional stakeholders to ensure change impact assessments include regulatory, quality, manufacturing, supplier, labeling, and clinical considerations as applicable.
- Ensure change documentation is complete, traceable, and aligned with quality system and product lifecycle requirements.
- Serve as the business process owner for QMS IT systems, partnering with IT and system vendors to maintain system functionality, user access controls, and compliance requirements.
- Support system configuration, enhancements, training, and troubleshooting to ensure high adoption and effective use.
- Ensur…
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