Position Summary:

This position provides operational quality support to the European business, including MDR Economic Operator activities, Post market surveillance activities, Quality Management System support, Supplier & Distributor Quality management, facilitating global quality initiative implementation, complaint handling, etc. Ensures and promotes adherence to regional and global Quality Management System policies and procedures.

The position supports the Sr. Director of Quality Europe with coordinating and managing audits, ensuring our 3PL partner and Service Center are compliant, and performing any critical supplier and distributor audits within the region. The position holder is expected to visit our offices in Den Bosch and Amsterdam on a regular basis

What will you be doing:

• Supports the implementation, certification and maintenance of the quality management system.
• Supports quality management system processes, such as document and record control, non-conformance, CAPA and change control.
• Develops and implements metrics to monitor and improve quality management system and business processes.
• Participates in internal, supplier, distributor and other audit programs.
• Develops and provides training to other functions on quality related topics.
• Develops and maintains working knowledge of relevant regulations and quality management system requirements.
• Monitors supplier performance, follows up on deviations and ensures that solutions are implemented.
• Monitors distributor performance, follows up on deviations and ensures that solutions are implemented.
• Supports the EU Authorized Representative and UK Responsible Person functions.
• Supports the EU Importer / Distributor requirements, by means of article inspections and follow up.
• Supports market expansions, including labeling, translations, local notifications and/or registrations.
• Remains industry-current through professional, technical or other societies.

A little about yourself:

• Bachelor’s degree in science, (biomedical) engineering, health sciences or equivalent.
• 5+ years in medical device industry or health institution.
• Working knowledge of ISO 13485 and EU Medical Device Regulation.
• Experience with conducting internal and/or supplier audits.
• Excellent project management, time management and analytical skills.
• Experience with cause analysis techniques, process and software validations.
• Fluent in spoken and written English; Dutch is preferred.
• Strong admin and IT skills, particularly Microsoft Office.

What we offer:

• With AtriCure, you'll get the opportunity to work with a team that is passionately dedicated to improving the lives of patients with Atrial Fibrillation worldwide. It is also a company that will invest in your professional development to help you grow and be successful in your role.

In Addition, AtriCure Also Provides:

• The chance to work with an international team with more than 20 different nationalities, with 130 international employees (on-site and in the field) which makes it a dynamic place to work.
• The offer includes a competitive base salary, Company bonus plan, Mobility policy, training and development opportunities, 28 days’ annual paid leave, 2 days’ volunteer time off + 1 cultural heritage day per year, mental health support benefit, and dynamic company events.

Our Process

Please apply through LinkedIn or on our website. We would like to get to know you better so please feel free to share ample information about yourself and why you are interested in working with us. Once we have your application, our International Recruiter will contact you to find out more about your background and your expectations. The next steps include a meeting with the hiring manager to focus on key information about the role and to potential fit into the team. If this round is successful, you will get to meet a few of our team members to give you diverse perspectives about AtriCure. After all the interviews, we conduct reference checks to help us make the final decision.

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