Product Quality Engineer
Job in
Risch-Rotkreuz, 6300, Zug, Kanton Zug, Switzerland
Listed on 2026-10-21
Listing for:
Actalent
Full Time
position Listed on 2026-10-21
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Quality Control - QC Analysts/Managers, Production QC/QA -
Engineering
Quality Engineering
Job Description & How to Apply Below
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
.
- 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
- 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
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