IVD Quality Engineer: GMP, ISO 13485 & Test Equipment

ITech Consult AG; Risch-Rotkreuz; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

ITech Consult AG in Rotkreuz, Switzerland, seeks a Product Quality Engineer to ensure regulatory-compliant testing of diagnostics products. You will define test equipment requirements, develop qualifications, and train teams on test procedures within a GMP environment.

The ideal candidate has a degree in Engineering or Natural Science or equivalent, with 3+ years in GMP manufacturing, and strong knowledge of ISO 13485/IVDR/FDA standards. Travel up to 10% is expected.

Qualifikationen

• Degree in Engineering, Natural Science or related disciplines or apprenticeship with subject matter expertise.
• 3+ years of GMP regulated manufacturing experience.
• Experience in IVD product manufacturing and testing.
• Knowledge of Process Management methodologies (Six Sigma, etc.).
• Ability to communicate across all levels of the organization.

Aufgaben

• Translate product specifications into test equipment requirements (URS).
• Define and develop test equipment and acceptance criteria.
• Create and manage test plans.
• Perform qualification and validation of test methods.
• Provide training on test procedures to stakeholders.
• Review and assess test equipment changes and FAI/tolerance.

Kenntnisse

Communication

English proficiency

Strategic thinking

Autonomous

Structured

Negotiation & influence

Ausbildung

Engineering/Natural Science degree

Jobbeschreibung

ITech Consult AG in Rotkreuz, Switzerland, seeks a Product Quality Engineer to ensure regulatory-compliant testing of diagnostics products. You will define test equipment requirements, develop qualifications, and train teams on test procedures within a GMP environment.

The ideal candidate has a degree in Engineering or Natural Science or equivalent, with 3+ years in GMP manufacturing, and strong knowledge of ISO 13485/IVDR/FDA standards. Travel up to 10% is expected.