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Validation Engineer Nr ref.: /JOBS.pl This company is a leading global provider of design and manufacturing services to the medical device markets, currently they are looking to hire talented Validation Engineers for their sites in Finland and in the Netherlands.6 to 12 Month contract - full time Key Job ResponsibilitiesMain responsibilities involve pre-production validation activities related to plastic injection molding, assembly and packaging of medical devices related products.Assuring compliance with ISO 13485, ISO 15378, ISO 2859, ISO 3951 and GAMP.Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.Conducting and participating in client meetings and risk management sessions.Assuring compliance with regulatory requirements 94/42-EEC, 21CFR Part 820, GMP.Updating and redacting critical product records, device master record (DMR) and bill of materials (BOM).Updating and defining Standard Operating Procedures (SOPs).Acting as the Quality and Validation responsible person for projects.Support manufacturing and operations for production and product industrialization. Skills and ExperienceCurrent knowledge of GMP and GAMP.Relevant and applicable technical or academic education, for example, engineer (the FDA requires validation training by an external entity, no later than 6 months from the position start date.)ISO 13485, ISO 15378, ISO2859, ISO3951 and regulatory requirements (incl. 94/42-EEC, 21CFR Part 820)Plastics material basics, the construction and technologies of injection molding tools and automation.Working with an implemented Quality Management System.An eagerness to learn.Good interpersonal skills and customer interaction. To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.In case you have difficulty in applying or if you have any questions, please call Sayf Jabbar on or upload your CV on our website . A full job description is available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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