IVD Quality Engineer — GMP, ISO 13485 & Validation Lead

ITech Consult AG; Rotkreuz; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

ITech Consult AG is seeking a Product Quality Engineer for Rotkreuz to lead the testing strategy for external manufacturing in the diagnostic workflow. You will translate specifications into test equipment requirements and drive qualification and validation activities in collaboration with RDI and suppliers.

The role requires a MSc/BSc in engineering or an equivalent apprenticeship with deep subject matter expertise, 3+ years in GMP environments, and fluency in German and English.

Qualifikationen

• M.Sc. or B.Sc. in Engineering or apprenticeship with high subject matter expertise.
• 3+ years of relevant work experience in a GMP regulated, producing company.
• Experience in IVD product manufacturing and testing.
• Knowledge of Lean, Six Sigma, or other process management methods.
• Experience with test equipment qualification and test method validation.
• Knowledge of ISO 13485, IVDR, and FDA 21 CFR Part 820 regulations.
• Strong communication in German and English, with travel up to 10%.

Aufgaben

• Transfer product specifications into test equipment requirements (URS).
• Define and develop test equipment and acceptance criteria.
• Create and implement test plans at supplier and RDI.
• Define sample sizes for IPC, product release testing, and incoming goods inspection.
• Conduct internal and supplier trainings on product quality inspection.
• Review test equipment qualification, test method validation, and FAI documentation.

Kenntnisse

Strategic thinking

Process Management (Lean / Six Sigma)

Communication (German & English)

Ausbildung

M.Sc. in Engineering

B.Sc. in Engineering

Apprenticeship in engineering (subject matter expert)

Jobbeschreibung

ITech Consult AG is seeking a Product Quality Engineer for Rotkreuz to lead the testing strategy for external manufacturing in the diagnostic workflow. You will translate specifications into test equipment requirements and drive qualification and validation activities in collaboration with RDI and suppliers.

The role requires a MSc/BSc in engineering or an equivalent apprenticeship with deep subject matter expertise, 3+ years in GMP environments, and fluency in German and English.