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Design Assurance Engineer (interim/freelance)
KEY WORDS: Process validation engineer, Validation engineer, Injection moulding, Operational excellence engineer, lean six sigma, CRA, CRM, Clinical research associate, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, Freelance, Interim, zzp, contract, project, temporary, pharma, ISO13485
For a client in the Amsterdam region I am urgently looking for a Design Assurance engineer.
Location: Randstad region
Contract duration:6 months + long term extension possibilities
My client is a leading manufacturer of components for Medical Devices. Originally from the U.S., they now have a global reach with plants in Europe, Asia and the U.S. They work closely with leading global pharmaceutical and Medical Devices organisations.
Supporting the development and design teams, the Design Assurance Engineer holds responsibility for the quality system compliance and evaluation of the DHF.
Furthermore, the Design Assurance engineer is responsible for:
*Document compliance to ISO and GMP standards
*The approval and reviewing of the design documents
*Assure that the product development processes and the correct documentation meet the standards listed in the Design and Development plans
*Lead risk management sessions
*Reviewing and approving all validation protocols submitted by the internal validation teams
*Train employees on industry standards
The Design Assurance engineer must have:
*Experience as a Design Assurance engineer in the Medical Device industry
*Knowledge on GMP, ISO 13485, and ISO 15378, 2859, 3951, FDA 21CFR820, and regulatory requirements are a bonus
*Experience with process validation for IM Tool
*Expertise on Quality Management Systems
*Knowledge on plastic materials basics
*BSc. + degree in relevant field
*Basic knowledge on Medical device directive 93/42/EEC, Risk Assessment 14971
*Strong communication skills and fluent in English
Are you interested in this role? Then please send your most up-to-date CV to (see below) and I'll get in touch with you as soon as possible.
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 or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
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