IVD Product Quality Engineer - GMP/ISO 13485 Expert

ITech Consult AG; Zug; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

ITech Consult is seeking a Product Quality Engineer for the IVD product manufacturing domain in Rotkreuz. You will plan and ensure testing aligns with GMP, ISO 13485, IVDR, and FDA 21 CFR 820, and drive test equipment qualification and validation activities.

The ideal candidate has a MSc/BE in Engineering or Natural Science with 3+ years' GMP experience, strong QA skills, and fluent German and English. Travel up to 10% is required.

Qualifikationen

• Degree in Engineering or Natural Science with GMP knowledge.
• Experience in IVD manufacturing and testing environments.
• Knowledge of QA and regulatory guidelines (ISO 13485, IVDR, FDA 21 CFR 820).

Aufgaben

• Transfer product specifications into test equipment requirements.
• Define and develop test equipment and acceptance criteria.
• Create test plans and implement testing at supplier and RDI.
• Determine sample sizes for IPC, product release, and incoming inspection.
• Train staff on product quality inspection procedures.
• Review test equipment qualifications and method validation.

Kenntnisse

GMP experience

IVD manufacturing

Test equipment qualification

Test method validation

Lean Six Sigma knowledge

German & English communication

Ausbildung

M.Sc or B.Sc in Engineering or Natural Science

Apprenticeship with high subject matter expertise

Jobbeschreibung

ITech Consult is seeking a Product Quality Engineer for the IVD product manufacturing domain in Rotkreuz. You will plan and ensure testing aligns with GMP, ISO 13485, IVDR, and FDA 21 CFR 820, and drive test equipment qualification and validation activities.

The ideal candidate has a MSc/BE in Engineering or Natural Science with 3+ years' GMP experience, strong QA skills, and fluent German and English. Travel up to 10% is required.