SENIOR QUALITY ENGINEER - Swiss Med Tech - CSV
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Details
Description
SENIOR QUALITY ENGINEER - exciting Medtech - German & English required
Located South of Zurich with good transport connections within Switzerland and beyond, our client is a small to medium sized Swiss company helping customers develop innovative products with a focus on mechatronics and medical technology including system development, design, hardware and software development, test and verification procedures,
Currently they seek a experienced, enthusiastic SENIOR QUALITY ENGINEER to join and support the team in quality tasks with a focus on qualification of production systems and validation of software systems.
Day to day activities will cover
- Creation & analysis of life cycle documents
- Development of validation strategies for complex systems, testing processes and manufacturing processes including their validation
- Execution and moderation of risk analyses
- Design of test cases and their execution
- Support of regulated companies or their suppliers
- Change management, deviation management
Typically we'd expect University training in a scientific or engineering discipline with a industry background of at least 3 years working in a regulated environment, ideally medical technology with ISO 13485, ISO 14971, 21 CFR Part 11. Industry experience should include CSV especially in validation of software systems of category 5 according to GAMP, experience in the qualification of production systems, knowledge of ALM and test automation, and with Business level German and English, as documentation is mostly in German and client customer contact tends to be in German.
For more information on this vacancy, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and work references.
KEY WORDS: CSV, Computer Systems Validation, Quality Assurance, QA, Compliance, document control, Change management, deviation management, risk management, ISO14971, labelling, non-conformities, MDR, Medical Devices, German, English, Switzerland, ISO 13485, ISO 9001, GAMP 5, 21 CFR Part 11, AAMI TIR36:2007 or ISO/TR 80002-2:2017, CAPA, Medical Device jobs, nonstop recruitment.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover
