Product Quality Assurance Specialist

vor 16 Stunden


Rotkreuz, Zug, Schweiz Randstad Vollzeit
Company Overview
Randstad, a leading global staffing firm, is seeking an experienced Product Quality Engineer to join their team. Our client is a medical diagnostics company that requires a highly skilled professional to ensure the highest level of product quality.

Job Description
The Product Quality Engineer will be responsible for ensuring and checking the product quality of assigned products across the entire assembly and testing chain. This includes specialist knowledge in manufacturing and testing processes in assembly and QC, as well as coordination between QA, R&D HW and SW, GCS, Technical Support, PQE QC Testing and Assembly.

Responsibilities
- Ensure product quality across the entire assembly and testing chain
- Evaluate and analyze quality data (e.g., trend analysis, statistical process control)
- Lead corresponding meetings in the product team
- Create requirements for test concepts, test planning, and test environments
- Carry out classification of tests and aids
- Create, update, review, and train specification documents, instructions, and reports

Required Skills and Qualifications
- Completed university or technical college degree in a scientific or technical field (e.g., bioengineering, medical technology, mechanical engineering) or apprenticeship as a laboratory technician with at least 5 years of professional and project experience in a diagnostic or molecular biology laboratory
- First professional or project experience 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 how to deal with test systems, test software, and complex hardware and software architectures

Benefits
- Unlimited contract via Randstad with a possibility of internalization
- Rotkreuz workplace with the possibility of working from home (20-40% but mostly on-site)
- Approximate team size of 21 people in the Production Engineering department

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