product quality engineer.

The team focuses on all aspects of product quality from the supplier through assembly to the testing process. This includes, among other things, the creation of the test concept, derivation of the test procedures, coordination of the test methods and the definition of test-relevant parameters. Our PQEs analyze the data from pilots and pre-series. These results are then used in the further development process to ensure good quality, a stable design and good manufacturability of the products. As part of the product care of the on-market products, our PQEs are represented in the PTM (Product Team Meeting) and also deal with all aspects of product and test quality there.


General information:

• Start date: ASAP
• Latest possible start date: May 1st, 2025 (earlier preferred)
• Duration: unlimited contract via Randstad (with a possibility of internalisation)
• Workplace: Rotkreuz
• Workload: 80-100%
• Home office: possible (20-40%) but mostly on-site
• Team: approx. 21 people
• Department: Production Engineering
• Working hours: standard

Tasks & responsibilities:
 

• Ensuring and checking the product quality of the assigned products across the entire assembly and testing chain
• Specialist in the manufacturing and testing processes in assembly and QC and coordinator between QA, R&D HW and SW, GCS, Technical Support, PQE QC Testing and Assembly
• Responsible for the evaluation and analysis of quality data (e.g. trend analysis, statistical process control) and leading corresponding meetings in the product team
• PQE representative in the Product Team Meeting (PTM)
• Creation of requirements for the test concept, test planning and the test environment. Carrying out the classification of the test and aids
• Creation, updating, review and training of specification documents, instructions and reports as well as validation and qualification documents
• Responsible for the creation and updating of the pFMEA, test planning, test specifications in collaboration with the departments concerned
• Processing of specific CAPA and change tasks
• Identifies and presents improvement measures and implements them in consultation with the product team
• Compliance with and ensuring all Q standards, guidelines, regulations and instructions as well as safety and environmental protection requirements, representing QM with regard to standard requirements

Must Haves:
 

• 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 (also as part of the degree) 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, SAP
• Basic knowledge of statistics
• Technical understanding of how to deal with test systems, test software and complex hardware and software architectures
• High level of commitment, ability to work in a team, flexibility and resilience
• Strong awareness of quality and a structured, scientific approach
• Very good written and spoken German and English

Nice to haves:

• Knowledge of R, Python MiniTab or JMP (or comparable tools)