Product Quality Assessor (m/f/d)

Contract duration: 12 months/will be extended

Workload: 100%

Responsibilities:

• 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 test equipment

Requirements:

• Excellent communication skills in German and English
• 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