Senior Clinical Quality Engineer

Anteris Technologies; Maple Grove (MN); On-site; USD 80,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Quality Engineer to ensure the quality and compliance of innovative medical devices. This pivotal role involves collaborating with cross-functional teams to uphold regulatory standards and enhance patient care. Join a forward-thinking company dedicated to revolutionizing structural heart solutions, where your expertise will directly impact the healthcare landscape. With a commitment to quality and innovation, this position offers a unique opportunity to contribute to groundbreaking therapies in a collaborative environment.

Benefits

Medical, Dental, and Vision Plans

401k + Company Match

Flexible Spending Account (FSA)

Life and Disability Insurance

Employee Equity Program

Paid Holidays & Vacation

Employee Assistance Program

Collaborative Work Environment

Qualifications

• 5+ years of experience in clinical quality engineering in the medical device industry.
• Strong knowledge of ISO 13485 and Good Clinical Practices.

Responsibilities

• Develop and maintain clinical Quality Management System (QMS) processes.
• Conduct risk assessments and develop mitigation strategies related to clinical trial quality.

Skills

Clinical Quality Engineering

Quality Management Systems (QMS)

Regulatory Compliance (FDA, ISO 13485)

Analytical Skills

Problem-Solving Skills

Communication Skills

Education

Bachelor’s degree in Biology or Biomedical Engineering

Advanced degree in related field

Job description

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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.

Primary 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.
  
  
  

** Anteris fosters an onsite work culture; however, for exceptional candidates located outside of Minnesota, relocation or remote work arrangements may be considered. **

Required Skills, Knowledge, Experience & Qualifications:

• 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).
  
  
  

Preferred Skills, Knowledge, Experience & Qualifications:

• 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.
  
  
  

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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