\\n QA Manager, strong QMS focus \\xe2\\x80\\x93 Complex MedTech products \\xe2\\x80\\x93 (German) Switzerland \\xe2\\x80\\x93 permanent role

Today I am looking for a QA Manager for a young Medical devices manufacturer located in Switzerland\\xe2\\x80\\x99s Central West. This is a great new role! Certified to ISO 13485, the company is focused on expanding their product markets over the next 2 -3 years, so it\\xe2\\x80\\x99s a particularly exciting time to join. Reporting directly to the CEO, this role will have a very strong focus in developing and maintaining the QMS including responsibility for quality compliance to ISO 13485, documentation & data management, Training, Quality Representative), and\\xe2\\x80\\xa6..

\\xe2\\x80\\xa6 duties will also extend to

• supplier quality agreements and audits
• implementing and maintaining CAPA and Risk Management systems
• support to development (V&V activities, maintenance of technical files)
• responsibility for pre-clinical and clinical trials, & preparation of clinical evaluation reports,
• Regulatory support in developing strategy to commercialize new products, compiling technical dossiers, leading interactions with regulatory bodies, and act as Person Responsible for Regulatory Compliance (PRRC).

This particular role needs someone with 5-6 years hands on industry experience in quality management & regulatory affairs within the Medical Devices sector, a working knowledge of ISO 13485/MDR/FDA 21CFR820, and with particular expertise in development and maintenance of Quality management Systems. (QMS experience within other tightly regulated industries will also be considered). Good communication skills are essential with English being the language of choice and German &/or French beneficial. A Lead Auditor certification, and experience in new product registrations for Europe and the US will also prove very useful.

This a permanent role, and key to continued growth and maintaining compliance to local and international regulations. It comes with a competitive salary and benefits, and good potential for career development. Interviews will be arranged at short notice, longer notice periods will also be considered.

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: Quality Assurance, QA, Compliance, QMS, Quality management, Quality System, Audit, document control, change management, risk management, labelling, non-conformities, deviations, MDR, Medical Devices, German, English, French, Switzerland, ISO 13485, ISO 9001, GMP, ISO 14971, GMP, ISO27001, 21CFR820, 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\\n \\n \\n \\n \\n \\n

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