Project:
The Global External Manufacturing team specializes in single-use injection-molded parts for diagnostic applications and is responsible for the development of new consumables, product maintenance, and ensuring supply. Suppliers are selected and managed in close collaboration with Purchasing. The team combines comprehensive expertise in areas such as tool technology, polymers, automation, product design, injection molding technology, and materials science.
Tasks:
- Evaluation of test results to ensure compliance with product-specific test specifications
- Responsibility for processing deviations and complaints including root cause analysis
- Risk assessment and derivation of appropriate measures (CAPA, SCAR, etc.)
- Processing of inspection lots
- Application and compliance with existing processes in the area of quality management and continuous improvement
- Collaboration in cross-functional teams for troubleshooting and process optimization
- Close cooperation with suppliers worldwide
Requirements :
- Completed studies in engineering (at least Bachelor's degree)
- At least 1 year of professional experience in external manufacturing
- Experience in the manufacturing and testing of IVD/medical devices
- Good knowledge of the relevant regulatory requirements in the field of in vitro diagnostics (e.g. IVDR)
- Strong quality awareness and analytical thinking skills
- Independent and structured way of working
- Teamwork and good communication skills
- Willingness to travel internationally occasionally (approx. 15%)
Languages:
- Good German (B2 or better)
- Good English (B2 or better)
Reference No.: 924347MH
Role: Product Quality Assessor (m/f/d)
Industry: Pharma
Place of work: Rotkreuz
Workload: 80-100%,
Start: 01.09.2025 – latest 01.12.2025
Duration: ++12 months / Extension option
Job Type: 80-100%
Work Location: On the road