Right now, I’m looking for a Supplier Quality 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 supplier quality of external companies. Next to that, 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.
- Works closely with Suppliers to collect, review and document their CE marking data and documentation for new device introductions into the EU
- Qualify suppliers within the global procedure. Support or Lead Product Supplier Audits
- Maintain and control the list of approved product suppliers for EU countries in accordance with quality system requirements
- Maintain/control list on devices that are imported and distributed into EU/EEA/UK.
- Create and maintain strong relationships and effective lines of communication with EU product Suppliers including contracts. Prepare and negotiate Supplier Quality Agreements with Suppliers.
- Manage and review Supplier change requests to ensure continuous compliance to applicable standards and collect and review the information for supplier performance
- Initiate and assist suppliers with CAPAs, Handle the product complaints, Evaluate and determine distributor controls
- Minimum 3 years’ experience in a RA or QA role and proven Supplier auditing experience
- At least 2 years of experience within Regulatory affairs and/or Quality Assurance.
- Minimum of a Bachelor’s degree in the Sciences or Engineering 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 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