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Quality Assurance and Regulatory Affairs Officer
Challenging and responsible position within a growing organization
Het bedrijf / The company
Our client is a medical device company which is founded in 1989 in The Netherlands. The mission of the organisation is to produce and sell copper Intrauterine Contraceptive Devices (IUD"s). This organization assures that their products may be used safely and that the products functions according to their intended use. Their product obtained the CE Marking of Conformity in 1996 and renewed it ever since. Within this organization there are short communication lines and a lot of challenging projects. They upgraded their ISO certificate at the start of 2019 and within their challenging market there are plenty of business opportunities. As part of their ambition to be successful, our client is searching for an experienced Quality Assurance and Regulatory Affairs Officer. In this position you will be part of a small team with dedicated professionals.
De functie / The role
As a Quality Assurance and Regulatory Affairs Officer you will be part of a small team who is responsible for the set-up, maintenance and improvement of the quality and regulatory required systems. These systems ensure that the company is able to fulfil the best quality and regulatory requirements for its products. In consultation with top management and experts this team will establish, implement and maintain processes for the quality management system. Together with your colleagues you will be responsible for internal and external audits, complaint handling, document control and control of records. Also, the department ensures that all employees of the organisation are aware of regulatory requirements and their impact. Furthermore, there are several other tasks like signing off all inspection related documents, initiation and implementation of corrective and preventive actions and reporting of design and quality management system changes.
Het profiel / Your profile
o at least a bachelor"s degree and academic experience
o experience within the medical device industry
o good analytical and system skills
o excellent communication skills, both internally and externally
o excellent language skills in English as well as in Dutch
o driven, self-starting and collaborative
Het aanbod / The offer
o challenging and responsible position
o a lot of responsibility
o varied range of duties
o plenty of room for own ideas
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/19-042-DD, to Tim van Loon : firstname.lastname@example.org.
For further information, please call Tim van Loon at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.