For our client specialized in medical devices, localized in the French part of Switzerland, we are looking for a 11 month-mission, a :
Senior Validation Engineer
Your responsibilities
- Review, update and implement EU MDR technical documentation for submission
- Provide support in developing and approve operating procedures, manufacturing control plans, pFMEA
- Ensures that validation and qualification activities are consistent with company validation policies and procedures and global regulations
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis
- Evaluate technical problems and provide recommendations for corrective actions
- Investigate deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature
- Demonstrate proficiency in applying various tools and methods (for example, Process Excellence) to identify and realize process and business improvements
- Collaborate with Global Supply chain, R&D, RA and material suppliers to ensure appropriate application of process validation, process control, and risk management
- Ensure that Process Quality control plans are in accordance with product risk level and are consistently followed. Implement and/or maintain production and process controls using appropriate techniques
- Ensure compliance according to Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements)
- Provide support during internal and external audits
Your profile
- Bachelor or Master degree in engineering sciences
- Minimum 5-year experience in quality
- Experience in statistics, Lean and Six sigma technologies
- Good knowledge of regulatory requirements concerning analytical test methods and licenses
- Fluent in French & English
Your application Please apply on-line. For more information, contact Ms Sophie Darthenay
