Quality Specialist (m/f/d) Permanent

My duties

• Ensure compliance to all work instructions in place (Quality documentation, Work instruction, Calibration, Records)
• Lead Process validation according to procedures in place and ensure Change Control is applied anytime significant change occurs on a process
• Review and assess all changes that could impact worst case Products or Parameters defined in current validation
• Check that the equipment used complies with its level of validation. Update VMP monthly
• Lead a X-functional team to perform Process risk analysis (PFMEA)
• Ensure all actions defined in PFMEA are implemented and verified
• Perform impact assessment of product modifications and compare to quality level of its line
• Ensure PFMEA are up to date
• Ensure compliance in the implementation of Process deviation (SI), according to procedures
• Alert QA supervisor if risk is identified and associated with a process deviation
• Develop a standard SOP upon needs

My qualifications

• Masters degree level, Medical Device Quality or mechanical
• Knowledge about ISO 13485 and ISO norms related to Cleaning, Packaging, Cleanroom and Sterilization processes
• Internal auditor (beneficial)
• GB certified (beneficial)
• Experience with problem solving tools as DMAIC, 5 Whys, KAIZEN (beneficial)
• Experience in statistical tools as R&R, SPC, Variance analysis (beneficial)
• Language: French, English

My benefits

• Interesting tasks in an international environment

About Hays

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays

Contact

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Reference number

592237/1