Quality and Regulatory Specialist BeNeLux

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Our company

With a strong belief that everyone needs to have access to the best possible health care, Getinge offers hospitals and life science companies and institutions, products and solutions to improve clinical results and to optimize workflows. Getinge’s selections includes products and solutions for intensive care, cardiovascular processes, operating theatres, sterilization departments and life science. Getinge employs over 10.000 people worldwide and sells its products in more than 135 countries.

Job description

The QA / RA Specialist Benelux (remote position) is assisting the QRC Manager Benelux for establishing and maintaining the global Quality Management System and identifying the opportunities for improvement. In Benelux, guarantee a QRC interface between customers, authorities and certification bodies and manufacturers, in order to satisfy customers and support business activities, and to ensure that the SSU’s are operating in a fully compliant way according to the regulations/ standards.

Key responsibilities

• Supporting the QRC Manager Benelux in all the Benelux QRC activities
• Assist in the Implementation, maintenance and control of the Quality Management System based on ISO9001 and ISO 13485.
• Coordinate and follow up (FSCA) Field Safety Corrective Actions and ship holds..
• Support sales organization in complaint handling and internal non conformities
• Identifying training needs and recommendations to achieve or maintain necessary employee competencies
• Ensure that QA procedures are implemented and maintained with all related processes at both locations in The Netherlands and Belgium,
• Initiating if needed and Support CAPA’s
• Participate in internal and external audits and follow up on the audit findings
• Assisting the QRC Manager with the preparation of the monthly QRC KPI’s (global and local)
• Assist the QRC Manager with the preparation of the management reviews.
• Interact if needed with the Authorities and Notified bodies
• Implement actions to achieve the defined targets

Knowledge, skills & experience

• About minimum 1+ years hands-on experience in Quality Assurance
• Good knowledge in QMS
• MS Office, SharePoint, E-learning, TrackWise
• Being an Auditor ISO 13485 and or ISO 9001 is an advantage
• Good knowledge in Medical device regulation (MDR) and local medical device regulations.
• Native language shall be French or Dutch with a very good knowledge of the other national language (French or Dutch) – verbal and written
• Excellent language skills in English – verbal and written

Working at Getinge means above all that you recognize yourself in our mission “Passion for life”. It gives you the opportunity to make an active contribution to our core values: Passion, Collaboration, Openness, Excellence and Ownership. Our organisation strives to develop our employees and give them career opportunities. The work culture is informal and transparent. You will work in a dynamic environment within a strong growing (inter)national organisation, with plenty of space for ideas and initiatives.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.