One of our main clients based in Rotkreuz (Switzerland) is looking for a Product Quality Engineer QC to support the assembly, quality control, technical approval and packaging of diagnostic equipment. The goal is to provide the best possible support for production to ensure smooth operations, the highest quality and quantity.
Please note that fluent in German is needed for this role. Furthermore, you are expected to travel 25% of the time to Mannheim.
Responsibilities
* Ensuring and verifying the product quality of the assigned products throughout the entire assembly test chain
* Professional approval of the assigned products and initiation of escalation in case of defective products
* Troubleshooting and technical support for approval tests in assembly and QC
* Creation, processing and technical review of deviations
* Coordination of messages for the processing of supplier errors that have occurred within 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 of specification documents, instructions and reports as well as technical review of validation and qualification documents
* Processing of specific CAPA and ECR tasks
* Specialist in the manufacturing and testing processes in assembly and QC as well as coordinator between QA, PQE Product Care, Production Engineering, Technical Support, QC and Assembly
* Implementation of CIP (continuous improvement process) measures
Requirements
* Completed university or technical college degree in a scientific or technical field (e.g. bioengineering, medicine, 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
* Initial professional or project experience (also as part of your studies) in a regulated GxP environment, ideally in medical technology, (ISO 13458, GMP, FDA 21 CFR 820)
* First experience in the GMP environment
* Basic knowledge of statistics
* Technical understanding in dealing with test systems, test software and complex hardware and software architectures
* Very good written and spoken German and English skills
Duration: 12 months
Home Office: Temporarily possible, on-site presence required
Travel: Yes, 25% (Mannheim)
While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.
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