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
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Product Quality Engineer Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
