IVD Quality Engineer — Test Method & Equipment Expert

Actalent; Risch-Rotkreuz; On-site; CHF 90,000 - 120,000; Full time

Job summary

Actalent is seeking a Product Quality Engineer to drive quality activities in a regulated environment. The role emphasizes test equipment qualification, test method validation, and robust test planning across internal and external suppliers.

You will translate specifications into URS, define acceptance criteria, and lead qualification efforts while collaborating with cross-functional teams to ensure compliance with ISO 13485, IVDR, and FDA 21 CFR Part 820.

Qualifications

• Degree in engineering or natural sciences or equivalent technical apprenticeship.
• Minimum 3 years in a GMP-regulated manufacturing environment.
• Experience with IVD product manufacturing and testing.
• Experience with test equipment qualification and test method validation.
• Knowledge of Lean Six Sigma methodologies.
• Familiar with ISO 13485, IVDR, and FDA 21 CFR Part 820 (preferred).

Responsibilities

• Translate product specifications into test equipment requirements (URS).
• Define and develop test equipment and acceptance criteria.
• Create and implement test plans with internal and external suppliers.
• Define sample sizes for IPC, product release testing, and incoming inspection.
• Perform and support test equipment qualification and test method validation.
• Review supplier qualification and validation documentation (FQI/IVD).
• Collaborate with suppliers and internal stakeholders.
• Provide training on product quality inspection and test procedures.
• Review First Article Inspections (FAI) and tolerances.

Skills

GMP experience

IVD testing

Test equipment qualification

Lean Six Sigma

Cross-functional collaboration

Communication skills

Education

BSc or MSc in Engineering/Natural Sciences

Job description

Actalent is seeking a Product Quality Engineer to drive quality activities in a regulated environment. The role emphasizes test equipment qualification, test method validation, and robust test planning across internal and external suppliers.

You will translate specifications into URS, define acceptance criteria, and lead qualification efforts while collaborating with cross-functional teams to ensure compliance with ISO 13485, IVDR, and FDA 21 CFR Part 820.