Right now, I’m looking for a QA/RA Specialist for a leading Medical Device company specialised in among others Orthopedics, Traumatology, Wound Care and Sport Medicines. For more than 150 years, this organisation is on a mission every day to improve the quality of life of patients.
In this position, the main focus is on the QMS. Next to that, you’ll be responsible for complying with the provisions of the MDR and work closely with Local Regulatory teams.
- Establish and maintain the QMS. Manage development, review, approval, and timely revision of site quality documents and ensure alignment between the Local and Global Quality Systems as well as applicable regulations.
- Lead CAPAs, Provide support for Field Safety Corrective Actions across the EU and investigations, Process complaints, Co-ordinate tender requests.
- Manage internal audit program.
- Manage the non-conformance record (NCRs).
- Responsible for awareness of quality system documents for all site employees.
- Minimum 1-2 years’ experience within the Medical industry, Cosmetics or Food industries.
- Minimum 2 years of experience within Regulatory affairs and/or Quality Assurance.
- Bachelor’s degree in a relevant discipline.
- Excellent communication in English, Dutch is a pre.
ORGANISATION AND OFFER
This company is a leader in sports medicine, orthopedics, traumatology and wound care and dedicated to serving patients. 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