QA & Risk Manager

Job

AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung machine, reducing patient impact and shortening recovery. AMT has finished patient
inclusion of a large-scale clinical trial in 2024 and the results will become available in 2025. The offices are in Utrecht (Science Park) and in Ede. As AMT continues to grow, we are looking for a: QA & Risk Manager.

In this critical role, you will be responsible for maintaining and optimizing the Quality Management System (QMS), setting up and managing the CAPA process, Change Control, Management Review, and Risk Management.

You will report directly to Maarten Arends, the Quality and Regulatory Director.

Key Responsibilities:

Maintain and enhance the QMS to ensure compliance with ISO 13485, MDR, and FDA regulations.
Establish and oversee processes as Change Control and CAPA.
Develop metrics to proactively identify areas for improvement and initiate necessary actions.
Lead the Risk Management team, managing risks in accordance with ISO 14971, and ensuring effective integration with QMS elements such as Change Control, Validation, and Design Controls.

Profile

At least a Bachelor’s degree in health science or life science field (e.g., biology, microbiology, chemistry, engineering, medical technology).
Experience in conducting ISO 13485 internal audits and Risk Management (ISO 14971).
Strong understanding of MDR and FDA regulatory requirements.
Excellent communication skills in English.
Adept at working in cross-functional, regional, and matrixed team environments, with a scale-up mindset.
Committed to continuous improvement and adaptability within a dynamic, fast-paced environment.

Benefits

Join AMT Medical, a dynamic scale-up poised to redefine cardiac care. Positioned at the forefront of innovation, AMT offers a collaborative and flexible work environment where your contributions significantly impact patient outcomes. AMT Medical offers a competitive salary and benefits package, along with substantial opportunities for professional growth and development.