Senior Clinical Quality Specialist
16 days ago
Minneapolis
Job DescriptionSalary: Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care.With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the worlds first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. The Sr. Clinical Quality Specialist is responsible for establishing, managing, and maintaining quality systems that ensure all clinical trial activities meet the highest standards of compliance, integrity, and reliability. This individual will play a key role in supporting global IDE trials for Class III medical devices, ensuring adherence to GCP, ISO 13485, and applicable regulatory requirements. The role requires expertise in clinical quality oversight, vendor management, and continuous process improvement to enable the successful execution of complex clinical programs. 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. Key Responsibilities: Clinical Quality Oversight: • Oversee quality assurance activities related to clinical trials, ensuring compliance with ISO 14155 and global regulatory standards., • Review and approve clinical trial documentation (protocols, CRFs, SOPs, monitoring plans, etc.) for adherence to quality standards., • Partner with internal teams and external vendors to ensure consistent application of quality requirements throughout trial execution. Quality Management System (QMS): • Develop, implement, and maintain QMS processes in alignment with ISO 13485, 21 CFR Part 820, and other applicable regulations., • Ensure QMS procedures are effectively implemented and adhered to across clinical operations, including outsourced CROs and vendors., • Maintain a robust document control system for all clinical quality-related documents. Auditing & Vendor Management: • Plan, lead, and conduct internal audits, as well as external audits of CROs, core labs, and other vendors., • Establish and maintain quality agreements with outsourced vendors and oversee performance monitoring., • Collaborate with vendors to ensure corrective actions are implemented and compliance is sustained. Risk Management & CAPA: • Identify and assess potential risks to clinical trial quality and develop proactive mitigation strategies., • Lead investigations of quality issues, including device complaints, investigational product handling/returns, and protocol deviations., • Manage the full CAPA lifecycle, ensuring timely implementation, follow-up, and verification of effectiveness. Training & Continuous Improvement: • Provide training to internal stakeholders and external partners on QMS, GCP, and clinical quality expectations., • Drive continuous improvement initiatives to ensure QMS processes are efficient, scalable, and supportive of evolving clinical trial needs. Skills, Knowledge, Experience, Qualifications • Bachelors degree in life sciences, engineering, or related field; advanced degree preferred., • Minimum of 5+ years experience in clinical quality, clinical operations, or quality assurance within the medical device industry., • Direct experience supporting Class III medical device IDE trials is required., • Strong knowledge of GCP, ISO 13485, 21 CFR Part 820, and ICH guidelines., • Proven experience conducting internal and external audits of clinical trial vendors (CROs, warehouses, labs)., • Demonstrated expertise in CAPA management, risk assessments, and vendor quality oversight., • Excellent communication, collaboration, and training skills with cross-functional and global teams., • Strong problem-solving skills and the ability to work independently in a fast-paced, growth-oriented environment. 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 Offerings, • Flexible Spending Account (FSA), • 401k + Company Match, • Life, AD&D, Short Term and Long-Term Disability Insurance, • Bonus Plan Eligibility, • Employee Stock Option Plan, • Paid Holidays & Vacation, • Employee Assistance Program, • Inclusive Team Environment Note: We may require proof of COVID-19 vaccination to comply with health institutions, 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. Wehave 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. remote work