Product Quality Engineering - QC

Product Quality Engineering - QC (m/f/d) Biomedical Research / Medical Technology / MS Office, SAP / GMP / relevant experience or laboratory technician training / German and English

Project: For our client based in Rotkreuz, we are looking for a Product Quality Engineering - QC (m/f/d)

Background: Instrument Operations Rotkreuz ensures the production and management of a complex portfolio of small to large analytical systems. Within this organization, the Production Engineering department is a support department with six different teams that assist with the assembly, quality control, technical release, and packaging of diagnostic devices. Our goal is to provide optimal support for production to ensure smooth processes, the highest quality, and quantity. As one of these six teams, the QC Product Quality Engineers are responsible for ensuring and verifying product quality. The ideal candidate holds a degree in a natural science field or has completed an apprenticeship as a laboratory technician with more than five years of professional experience. Furthermore, the individual has experience in the regulated GxP environment of medical technology, as well as strong IT skills and basic knowledge of statistics. Finally, excellent German and English skills are required.

Tasks & Responsibilities: • Ensuring and verifying the product quality of assigned products throughout the entire assembly and testing chain • Technical release of assigned products and initiating escalation in the case of defective products • Troubleshooting and technical support for release tests in assembly and QC • Creation, processing, and technical review of deviations • Coordination of quality notifications for handling supplier errors that have arisen during production • Responsible for the evaluation and analysis of quality data as well as regularly conducting the Product Quality & Data Cycle Meeting • Creation, updating, review, and training on specification documents, instructions, and reports, as well as technical review of validation and qualification documentation • Handling specific CAPA and ECR tasks • Specialist for manufacturing and testing processes in assembly and QC as well as coordinator between QA, PQE, Product Care, Production Engineering, Technical Support, QC, and assembly • Identifies and presents improvement measures and implements them in consultation with Production Engineering • Implementation of CIP (Continuous Improvement Process) measures • Informing superiors about the current activities as well as in case of testing/equipment technical difficulties • Compliance with and ensuring all Q standards, guidelines, regulations and instructions as well as the • Safety and environmental protection requirements, representing the QM regarding standard requirements • Technical deputization according to the deputy list

Must-haves: • Completed university or university of applied sciences degree in a natural science or technical field (e.g., bioengineering, medical technology, mechanical engineering) or vocational training as a laboratory technician with at least 5 years of professional and project experience in a diagnostic or molecular biology laboratory • Initial professional or project experience (also gained during studies) in a regulated GxP environment, ideally in medical technology (ISO 13458, GMP, FDA 21 CFR 820) • Initial experience in a GMP environment • Very good knowledge of MS Office and SAP • Basic knowledge of statistics • Technical understanding of test systems, test software, and complex hardware and software architectures • High level of commitment, teamwork skills, flexibility, and resilience • Strong quality awareness and a structured, scientific approach • Excellent written and spoken German and English skills

Nice to have: • Knowledge of R, Python, MiniTab or JMP (or comparable tools)

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p>Reference No.: 924695 Role: Product Quality Engineering - QC (m/f/d) Industry: Pharma Location: Rotkreuz Workload: 100% Start: February 1st, 2026 Duration: 12++ Months j4id10031886a j4it0103a j4iy26a