Quality Assurance Manager - Medical Devices

Van Oostveen Medical B.V. - Romed Holland

Wilnis, Pays-Bas

Romed Holland – Van Oostveen Medical BV

Our company has been active in medical disposables for over 35 years and our quality assurance team consists of 2 staff members. Now we are looking for another a colleague to ensure MDR compliance and maintain interaction with the notified bodies as well as with our customers who are all over Europe, as well as in Holland. For further information, please visit our website www.romed.nl

MAIN RESPONSIBILITIES

• Ensure compliance with ISO13485, MDR and other relevant regulations

• Define the Quality goals each year

• Continuous improvement of company’s processes

• Internal- and external audits

• Support registrations and new product submissions

• Management review, SOPs, CAPA’s, Complaint Handling

YOUR PROFILE

• Relevant bachelor’s degree (or equivalent) in a relevant area

• At least a couple of years experience in a Medical Devices environment

• Good knowledge of ISO13485, MDR and MDD is preferred

• Excellent communication English. ... More Detail

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