Product Quality Assessor m/f/d, ZugGlobal External Manufacturing is the competence center for single-use injection molded parts in the diagnostic workflow. This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.
As a Product Quality Assessor, you are responsible for the evaluation of the test results to ensure the products meet the required test specifications. Furthermore, this role is responsible for processing deviations and field complaints, including root cause analysis, risk classification, and definition of appropriate mitigations.
Location: Rotkreuz
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
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