Beschreibung
Product Quality Engineer Serie: Validation/QC/Medical/GermanProject: For our customer, Roche Diagnostics International in Rotkruesz, we are looking for a motivated Product Quality Engineer who is responsible for products cobas.
Background :
PQE QC Testing ensures the technical release of the products according to the quality requirements of the product. If an error occurs during production or testing, a deviation report is created and processed by PQE's QC Testing department by analyzing the error, creating a risk assessment and, in cooperation with the necessary interfaces such as development and production, eliminating the error. In order to avoid errors, systematic data analyses are carried out regularly, processes are checked and revised if necessary
Tasks and areas of responsibility:
- He/she will be responsible for creation, updating, review and training of specification documents, instructions and reports as well as technical review of validation and qualification documents.
- Processing and technical review of deviations as well as technical release of assigned products
- Support of the quality management and ensure that regulated activities are carried out efficiently, effectively and in accordance
- Support of the troubleshooting at the assigned analysis system in case of complex deviation reports - Identification and presentation of improvement measures and implementation in consultation with the product team.
- Interface between R&D, assembly, system testing and QA to find constructive solutions in case of deviations and to achieve a smooth release.
- Development and maintenance of quality standards and metrics for key activities - Main responsibility for the deviation management of one or more products.
- Responsible for the evaluation and analysis of quality data (e.g., product specifications, product specifications, product specifications, etc.)
-Responsible for evaluating and analyzing quality data (e.g. Right First Time, Deviation Reports) and chairing meetings in the Product Team
Must Haves:
- University of Applied Sciences degree in a scientific/medical engineering field or a technical education with at least 2 years of professional experience in the medical engineering field****
- At least 2 years of experience in quality assurance****
- Experience in the regulated GxP environment, ideally in medical engineering (ISO 13485, GMP, FDA 21 CFR 820) in the area of deviation management****
- Native speaker of German or comparable level***
- You have a pronounced quality awareness and a structured, scientific approach is a matter of course*** - Good command of English fluent in writing (documentation)**
Nice to Haves:
- In-depth IT knowledge (MS Office, Tableau)
- SAP knowledge
- Understanding of complex hardware and software architectures
-You value independent and responsible work in a versatile product and project environment
Languages : German spoken and written fluently
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Reference No .: 919242NC
Role : Product Quality Engineer
Industry : Medical
Work : Rotkruez
Workload : 100%
Start : ASAP
Duration : 12 months
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