Product Quality Engineer
Coopers Group AG
- Engineering - Quality Management
- Zug
- Contracting
- Vollzeit
- Medizintechnik, Quality
Tasks & Responsibilities
- Transfer product speci-cation into test equipment requirements (URS)
- De-ne and develop test equipment
- De-ne acceptance criteria for test equipment
- Accountable for creation of test plan
- Implementation of test planning at supplier and RDI
- De-ne sample size for in-process control (IPC), product release testing and incoming goods inspection
- Conduct internal and supplier trainings regarding product quality inspection
- Accountable for test equipment quali-cation, test method validation, including correlation studies to RDI test equipment
- Technical Q&V documentation review at supplier regarding test equipment quali-cation, test method validation
- Responsible for review of -rst article inspection (FAI) incl. veri-cation of the tolerance situation
- Technical assessment of changes of test equipment and test planning
Must Haves
- M.Sc- or B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
- 3+ years of relevant work experience in a GMP regulated, producing company
- Experience in IVD product manufacturing and testing
- Knowledge of Process Management methodologies (Lean, Six Sigma, etc.)
- Experienced in test equipment quali-cation and test method validation
- In-vitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820
- 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 building rapport
- Performing well under pressure and decisiveness
- Excellent communication skills in German and English
- Travel required up to 10%
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Données OFS 2024 —
6'577 CHF / mois
Fourchette : 5'642 – 7'765 CHF (P25–P75), brut avant charges.
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