Quality Test Engineer – IVD Equipment & Validation

Coopers Group; Rotkreuz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Coopers Group is seeking a qualified specialist to translate product specifications into robust test equipment and validation plans in a GMP/IVD setting. The role focuses on test equipment qualification, method validation, and ensuring compliance with ISO 13485, IVDR, and FDA guidelines.

You will work cross-functionally, manage test plans, and guide supplier and internal teams. Travel up to 10% is expected, with strong communication in German and English a must.

Qualifikationen

• MSc/BSc in Engineering or Natural Science or apprenticeship with high expertise.
• 3+ years in GMP regulated, production environment.
• Experience in IVD product manufacturing and testing.
• Knowledge of Process Management methodologies (Lean, Six Sigma, etc.).
• Experience in test equipment qualification and test method validation.
• Knowledge of in-vitro diagnostic regulations (ISO 13485, IVDR, FDA 21 CFR part 820).
• Ability to think strategically and systemically, open to changes.
• Self-motivated, autonomous, structured and goal-oriented with a solution focus.

Aufgaben

• Transfer product specifications into test equipment requirements (URS).
• Define and develop test equipment.
• Define acceptance criteria for test equipment.
• Accountable for creation of test plan.
• Implement test planning at supplier and RDI.
• Define sample size for IPC, product release testing and incoming goods inspection.
• Conduct internal and supplier trainings on product quality inspection.
• Accountable for test equipment qualification and test method validation including correlation to RDI equipment.
• Review technical Q&V documentation at suppliers for qualification/validation.
• Review first article inspection (FAI) and verify tolerance data.
• Assess changes to test equipment and planning from a technical standpoint.

Kenntnisse

Strategic thinking

Systemic thinking

Communication skills

Autonomous working

Pressure handling

Change management

Team collaboration

Leadership potential

Ausbildung

MSc/BSc in Engineering or Natural Science

Apprenticeship with high subject matter expertise

Jobbeschreibung

Coopers Group is seeking a qualified specialist to translate product specifications into robust test equipment and validation plans in a GMP/IVD setting. The role focuses on test equipment qualification, method validation, and ensuring compliance with ISO 13485, IVDR, and FDA guidelines.

You will work cross-functionally, manage test plans, and guide supplier and internal teams. Travel up to 10% is expected, with strong communication in German and English a must.