Description
On behalf of one of our largest clients based in Rotkreuz, Switzerland, we are looking for a Product Quality Engineer to support our client!
Duties and Responsibilities
Ensure and check the product quality of assigned products across the entire assembly and testing chain.
Act as a specialist in manufacturing and testing processes in assembly and QC, coordinating between QA, R&D HW and SW, GCS, Technical Support, PQE QC testing, and assembly.
Evaluate and analyze quality data (e.g., trend analysis, statistical process control) and manage corresponding meetings in the product team.
Represent PQE in the Product Team Meeting (PTM).
Create requirements for the test concept, test planning, and test environment. Implement the classification of test equipment and resources required.
Create, update, review, and train on specification documents, instructions, reports, as well as validation and qualification documents.
Responsible for the creation and updating of pFMEA, test planning, and test specifications in collaboration with concerned departments.
Process specific CAPA and change tasks.
Identify and present improvement measures and implement them in consultation with the product team.
Ensure compliance with all Q standards, guidelines, regulations, and instructions, as well as safety and environmental protection requirements, representing QM with regard to standard requirements.
Requirements:
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 the regulated GxP environment, ideally in medical technology (ISO 13458, GMP, FDA 21 CFR 820).
Initial experience in a GMP environment.
Technical understanding of how to use test systems, test software, and complex hardware and software architectures.
Very good written and spoken German and English skills.
Skills
Engineering
Quality
HW
SW
Manufacturing processes
CAPA
PFMEA
PTM
PQE
QC
Employee Value Proposition
Roche is a global leader in Diagnostics & is a top employer in CH.
Job Title: Product Quality Engineer
Location: Rotkreuz, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121.
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