Anteris Technologies · 22 hours ago
Quality Systems Manager
Maple Grove, MN
Full-time
Onsite
Senior Level
5+ years expAnteris Technologies is a science-driven structural heart company that is redefining expectations in the medical device field. The Quality Systems Manager will lead the implementation and continuous improvement of the Quality Management System, ensuring compliance and operational excellence while supporting product development and manufacturing.
BiotechnologyHealth CareMedical
No H1B
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
Ensure system workflows support audit-ready records, data integrity expectations, and inspection readiness
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
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
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
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
Qualification
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
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
Inclusive Team Environment
Company
Anteris Technologies
Anteris Technologies is a structural heart company focused on developing innovative & durable health solutions.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$234.29MKey Investors
Partners for Growth
2026-01-22Post Ipo Equity· $200M
2023-02-09Post Ipo Equity· $24.29M
2017-10-01Post Ipo Debt· $10M
Leadership Team
Wayne Paterson
CEO and Managing Director
David St. Denis
Chief Operating Officer
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-22
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