Quality Systems Manager

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

1) Quality Management System (QMS) Leadership & Continuous Improvement

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.

2) CAPA Program Ownership & Effectiveness

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.

3) Document Control, Training & Compliance Execution

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.

4) Change Control & Configuration Management

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.

5) QMS IT Systems Ownership (eQMS / Quality Tools)

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.

Ensure system workflows support audit-ready records, data integrity expectations, and inspection readiness.

6) Internal Audit Program Leadership

Lead the internal audit program to ensure the annual audit schedule is developed, published, and executed as planned.

Plan and conduct internal audits and/or coordinate audits with trained internal auditors.

Ensure audit findings are clearly documented, appropriately classified, and linked to effective corrective actions where required.

Identify systemic issues and drive continuous improvement based on audit results and quality trends.

7) External Audit and Inspection Readiness

In partnership with the VP of Quality, support planning and execution of external audits and inspections, including Notified Body audits, customer audits, and FDA inspections.

Lead front room and back room coordination as assigned, ensuring preparedness of SMEs, documentation, and responses.

Ensure audit observations are captured accurately, addressed with appropriate rigor, and supported by timely, compliant responses.

8) Management Review & Quality Metrics

Lead quality system planning processes and support preparation of Management Review materials in alignment with ISO and regulatory expectations.

Track, trend, and publish monthly QMS performance metrics (KPIs), such as CAPA performance, audit findings, training compliance, document/change control cycle times, and quality system health indicators.

Present insights and recommendations to leadership, driving data-based prioritization and improvement actions.

9) Cross-Functional Quality Partnership & Culture

Promote a culture of quality, accountability, and continuous improvement across the organization.

Coach and influence stakeholders to strengthen compliance, risk-based decision-making, and proactive issue identification.

Provide guidance and training to teams on quality system requirements and best practices.

Skills, Knowledge, Experience & Qualifications

Required

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

Preferred

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.

Key Success Factors

Ability to balance compliance rigor with practical execution in a fast-moving environment.

Strong ownership mindset, with a bias toward action and measurable results.

Proven ability to lead programs, manage priorities, and drive closure on commitments.

Demonstrated strength in inspection readiness, documentation quality, and audit performance.

This is a unique opportunity to directly impact our mission, vision, and values as we take the company to the next level of growth and success.

What We Offer:

Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.

Collaborative and dynamic work environment with a culture of innovation and excellence.

Competitive compensation package, including salary, performance-based bonuses, and stock options.

Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings:

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

Inclusive Team Environment

Note: We may require proof of COVID-19 vaccination to comply with the 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, multiculturism 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.