Product Quality Assessor

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client Roche Diagnostics in Rotkreuz, we are looking for a motivated and reliable (m/f/d)

• Responsible for processing the inspection lots
• Responsible for Improvement & Resolution Management according to effective processes including non-conformities, CAPA, SCAR, WVP, etc.
• Responsible for the compliant coordination and execution of the deviation and complaint process and the corresponding KPIs
• Determine the inspection sample size and test criteria
• Responsible for communication with suppliers regarding quality assessments
• Act as point of contact to the inspection center
• Evaluate test results
• Responsible for management of Roche owned test equipment

• B.Sc. or M.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• 1-3 years years of work experience in External Manufacturing Business
• Experience in IVD/MD product manufacturing and testing, preferably in injection molding Technology
• Track record of experience with deviation and complaint handling in the highly regulated environment
• Sound knowledge in In-vitro diagnostic related regulations, such as ISO 13485, IVDR/MDR, FDA 21 CFR part 820 etc.
• Knowledge of Process Management and statistical methodologies (Lean, Six Sigma, etc.) - Green Belt certification preferred ****
• Ability to think strategically and systemically, willingness to try new ideas and participate in changes
• Self-motivated, autonomous, structured and goal-oriented mindset with a solution oriented balance of short term mitigation and long term solution
• Ability to effectively communicate with all levels of the organization by establishing credibility and trust
• Performing well under pressure and decisiveness
• Excellent communication skills in German and English