Right now, I’m looking for a QA/RA Specialist for a leading Medical Device company specialised in Wound Care. For more than 75 years, this organisation is on a mission to improve the quality of life.
In this position, you’ll be responsible for complying with the provisions of the EU MDR and you’re able to provide advise as part of a new Regulatory structure that is being established.
- Maintain list on devices that are imported and distributed into EU.
- Create and maintain strong relationships and effective lines of communication with interal and external stakeholders.
- Initiate and assist with CAPAs and handle the product complaints
- Works closely with stakeholders to collect, review and document their CE marking data and documentation for new device introductions into the EU
- Maintain and control the list of approved product suppliers for specific countries in accordance with quality system requirements
- Minimum 2 years’ experience in a RA or QA role and proven auditing experience
- Minimum of a Bachelor’s degree in the Sciences area
- Excellent communication in English, Dutch is a pre.
- Demonstrate strategic thinking with tactical and operational experience to deliver objects/results
- Proven ability to influence cross-functional teams and strong planning and analytical skills.
ORGANISATION AND OFFER
This company is a leader in wound care and dedicated to improve the quality of life. At the same time, they continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for the company, the customers and their patients.
The organisation offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org