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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