Senior Clinical Quality Engineer

Anteris Technologies • Maple Grove, MN

276d • Remote

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. We are seeking a Sr Clinical Quality Engineer who will play a critical role in ensuring the quality, safety, and compliance of Anteris products during our clinical trials. This position involves collaborating with global, cross-functional teams to develop, implement, and maintain quality systems and processes that comply with global regulatory requirements and industry standards. 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 in Biology, Biomedical Engineering, Clinical Engineering, or a related technical field. Advanced degree preferred.
• Minimum of 5 years of experience in clinical quality engineering in the medical device industry, with Class III devices.
• Experience with quality management systems (QMS) and regulatory requirements (e.g., FDA, ISO 13485 & 14155).

Nice To Haves

• Knowledge of TAVR procedures and related clinical practices strongly desired.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Detail-oriented with a strong focus on quality and compliance.
• Ability to manage both day-to-day operations as well as project work in fast-paced environment.
• Ability to multi-task and adjust priorities as necessary.
• Must be self-motivated and able to work autonomously.
• Excellent written/verbal communication and presentation skills.

Responsibilities

• Develop, implement, and maintain the clinical Quality Management System (QMS) processes to ensure compliance to applicable regulations and standards (e.g., ISO 13485, EU MDR, and 21 CFR Part 820)
• Develop, implement, execute and oversee quality assurance practices related to clinical trials to ensure compliance with Good Clinical Practices (GCP) guidelines.
• Ensure QMS procedures are effectively implemented and adhered to across all clinical operations, including those outsourced to CROs and other vendors.
• Create/manage/maintain quality and clinical audit plans. Perform and/or manage staff performing quality audits of investigator sites and clinical vendors.
• Conduct risk assessments and develop risk mitigation strategies related to clinical trial quality and compliance.
• Monitor and analyze clinical data to identify trends and areas for improvement.
• Collaborate with R&D, regulatory, and clinical teams to ensure compliance with Anteris requirements.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) associated with clinical product performance.
• Provide training and support to clinical staff on quality and regulatory requirements.
• Stay current with industry trends, regulatory changes, and best practices in TAVR and clinical quality engineering.
• Perform and/or manage quality reviews of clinical study documents, which include but is not limited to investigator brochures, clinical protocols and clinical study reports, case report forms, informed consents forms, DSURs, clinical study plans, protocol deviations, and protocol amendments.
• Participate in the review and approval of regulatory submissions.
• Perform/manage internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP regulations, standards, and guidelines.

Benefits

• 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.
• 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

What This Job Offers

• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree