Product Quality Engineer

Actalent; Risch-Rotkreuz; Sur place; CHF 90 000 - 120 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

GMP experience

IVD testing

Test equipment qualification

Lean Six Sigma

Cross-functional collaboration

Communication skills

Formation

BSc or MSc in Engineering/Natural Sciences

Description du poste

We are looking for a Product Quality Engineer to support quality activities within a regulated environment. The role focuses on ensuring that products and test processes meet applicable quality and regulatory requirements, with particular emphasis on test equipment qualification, test method validation, test planning, and statistical sampling.

Tasks & Responsibilities

• Translate product specifications into test equipment requirements (URS)
• Define and develop test equipment and corresponding acceptance criteria
• Create and implement test plans internally and at external suppliers
• Define appropriate sample sizes for in-process control (IPC), product release testing, and incoming goods inspection
• Perform and support test equipment qualification and test method validation
• Conduct correlation studies between supplier and internal test equipment
• Review technical qualification and validation documentation from suppliers
• Review First Article Inspections (FAI), including verification of tolerances
• Assess changes related to test equipment and test planning
• Provide training on product quality inspection and test procedures
• Collaborate closely with suppliers and internal stakeholders

Requirements

• BSc or MSc in Engineering, Natural Sciences, or a related discipline, or relevant technical apprenticeship with significant subject matter expertise
• Minimum 3 years of relevant experience in a GMP-regulated manufacturing environment
• Experience in IVD product manufacturing and testing
• Experience with test equipment qualification and test method validation
• Knowledge of process improvement methodologies such as Lean and Six Sigma
• Good knowledge of relevant IVD/medical device regulations and standards, including ISO 13485, IVDR, and FDA 21 CFR Part 820
• Structured, autonomous, and solution-oriented way of working
• Ability to communicate effectively with different stakeholders and work in a cross-functional environment
• Excellent German and English communication skills