RAQA Manager (QMS) - Key German affiliate of Swiss MedTech HQ
Exciting stuff - a new position to look after everything Qualtiy Assurance and Regulatory Affairs on site. Ours is a small/medium size company based in Northern Germany, developing and manufacturing complex mechanical / electronic products for noninvasive monitoring of blood parameters in for example surgical operating theatres in hospitals.
The role will cover regulatory submissions in the EU as well as the USA, liaising with local and international Regulatory Bodies, taking on the development, improvement, and maintenance of the Quality management system, preparation and management of audits, and ensuring a good quality culture is developed internally from the start.
Ideally someone with solid RA/QA experience within the Medical Devices industry and electronic products, and a number of product ranges will slot into this role well. Experience with ISO 13485, ISO 9001, GMP, experience with technical files and CE Marking and submissions generally into multiple markets.
English and German essential.
There are big plans for the future, and This role offers tremendous opportunities, working closely with their counterparts in Switzerland.
For more information on this vacancy, or any other QA opportunities within the DACH Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, or email him at firstname.lastname@example.org together with scanned certifications of training and Arbeits Zeugnisse.
For industry news and new opportunities in QA within the Medical Devices and Diagnostics sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en
KEY WORDS: QMS, Quality Management System, Germany, Switzerland, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, French, German, ISO 13485, ISO 9001, GMP, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering
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