Company: Amoria Bond
Closing Date: 23 Jan 17
Salary (£): Negotiable
Amoria Bond is urgently looking for a freelance/interim/temporary quality engineer to work for one of Europe’s most prominent medical devices companies, based in the Dutch province of Noord Holland. ...
Amoria Bond is urgently looking for a freelance/interim/temporary quality engineer to work for one of Europe’s most prominent medical devices companies, based in the Dutch province of Noord Holland.
You will report directly to the Director of RA and Quality and you will be responsible for ensuring an efficient and up to date Quality Management System, regulatory submissions in the field of medical goods focused on disposables, translating of the business strategy into a plan for the RA/QA team, management representative according to ISO 13485/ISO9001, releasing of quality documents (e.g. Incident Reports, deviation reports) in conformance with the Quality Management system, and managing a quality engineer.
Moreover, you will be advising on and coordinating the approval and registration of medical devices and related products, informing the business unit on the latest changes in guidelines requirements and directives, reporting on the performance of the Quality System to management with executive responsibility, collecting data and prepare submissions to regulatory agencies, composing and controlling quality/regulatory documentation, and the impact of changing regulations on the corporate product portfolio and procedures.
Skills we are looking for:
• Good experience (preferably 3+ years) in a pharma or medical devices role
• Excellent knowledge of ISO 13485, FDA 21CFR820, or MDD 93/42EEC
• Excellent Interpersonal and communication skills.
Candidates whom are interested or want to learn more about the role or position, can send an e-mail with their CV (in word-format) to Laetitia Fioole at Laetitia.FiooleCV@amoriabond.com.
Key search terms: medical devices, regulatory, RA, QMS, system, Nederland, quality, QA, Freelance, Interim, zzp, contract, project, temporary,
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age and experience, and we confirm that we are happy to accept applications from persons of any age and experience for this role.
Keizersgracht 270, 1016 EV Amsterdam, Nederland.
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