Senior QA Engineer, Design Assurance * IVD * Austria *
Senior Quality Engineer * IVD * Austrian reliability *
Here is a leader in the Diagnostics sector developing and manufacturing medical devices globally. Currently a Senior Quality Engineer is sought to take responsibility for product and process quality in projects, which primarily includes ensuring process conformity by supporting and monitoring the project teams (risk management, verification, derivation of test plans, first-level documentation review, change management, etc.) and with an emphasis on Design Assurance.
Other respopnsibilities to include
- Monitoring and ensuring compliance with regulatory requirements
- Support of the interdisciplinary development team in statistical experimental design and technical documentation
- Creation and training of process documents
- Multi-site collaboration internationally in international research and development projects
- Audit Support
- Technical leadership of a team
Typically this role would require a degree qualified QA professional with at least 5 years industry experience in implementing regulatory requirements to ISO 13485 in the product development environment, and with additional experience leading a team. Additional quality training, and in the application of statistical methods is a bonus.
Fluency in German is a Must, English is the corporate language.
This being a replacement role, they are keen to move on it quickly and interviews will be organised at short notice.
For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, and email him at firstname.lastname@example.org ahead of a confidential discussion of this opportunity. For industry news and new opportunities in QA within the Medical Devices & Diagnostics sectors, please also join my Linked group ch.linkedin.com/in/qaswitzerland/en
KEY WORDS: Quality Assurance, QA, Compliance, Auditor, Medical Devices, Austria, Switzerland, ISO 13485, ISO 9001, ISO 14971, GMP, CAPA, Corrective action, preventative action, Design Control, Design Assurance, Medical Device jobs, nonstop recruitment
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