Elan Personal AG
Product Quality Engineer
Rotkreuz · ZG
- Berufsfeld
- Produktion & Fertigung · Qualitätsprüfung & Warenkontrolle
- Ausbildung
- Bachelor
- Erfahrung
- 2 bis 5 Jahre
- Sprachkenntnisse
- Englisch
- Lohn
- Geschätzt CHF 90’000–120’000 pro Jahr (100 %)
- Schätzung von jopp, nicht aus dem Inserat.
- Veröffentlicht am
- 05. Oktober 2026
- Zuletzt gesehen
- 05. Oktober 2026
Elan Personal AG is recruiting for its client Diagnostics International AG in Rotkreuz for a temporary assignment. The role in External Manufacturing covers test planning, equipment and method qualification, product testing and supplier quality for diagnostic products.
Tasks
- Translate product specifications into test equipment requirements (URS)
- Define and develop test equipment and its acceptance criteria
- Create test plans and implement them at suppliers and RDI
- Set sample sizes for IPC, product release testing and incoming goods inspection
- Train internal and supplier stakeholders on product quality inspection
- Review test equipment qualification, test method validation, FAI and related changes
Requirements
- Engineering, Natural Science or related degree, or apprenticeship with high subject matter expertise
- At least 3 years of relevant experience in a GMP-regulated manufacturing company
- Experience in IVD product manufacturing and testing
- Knowledge of Process Management methodologies, such as Six Sigma
- Experience in test equipment qualification and test method validation
- Knowledge of IVD regulations such as ISO 13485, IVDR and FDA 21 CFR part 820
- Excellent communication skills in English; travel up to 10%
Offer
- Further training through temptraining
Summarised by jopp from the advert. The original advert is authoritative.