Quality Assurance Specialist - IVD/Diagnostics - Switzerland = French/English
This is a growing company. Well respected in Diagnostics circles for products and automated testing of blood and serum samples, they are a global manufacturer and with HQ in scenic French Switzerland. Intent on ensuring QA staff numbers are aligned with Business needs, they are seeking a French / English speaking Quality Assurance specialist.
Responsibilities to include management of the internal audit plan, conducting internal and supplier audits, coordinating the activities for site inspections, key indicators on process improvement, Management Review, and updating the Quality manual. You will evaluate and approve change requests, perform investigations and ensure the
follow up of deviations and CAPAs, while supporting the management of Quality projects within the organisation. Training sessions will follow to update staff on the Quality Management System.
Typically you will be degree qualified in Applied Sciences or similar, wit 3-5 years medical devices industry experience, preferably including IVD or biotechnological diagnostics experience as part of that. Active hands on familiarity with local (and FDA) standards ISO 13485, ISO 9001 and ISO 14971 are expected, while an analytical midset and finding pragmatic solutions are beneficial.
While French is the local language, English is essential and German a plus.
The job is varied, the product range is broad, and with good career development potential.
For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 817, and email him at firstname.lastname@example.org ahead of a confidential discussion of this opportunity.
KEY WORDS: Quality Assurance, QA, Compliance, Compliance specialist, Quality Engineer, Medical Devices, Switzerland, ISO 13485, ISO 9001, ISO 14971, GMP, CAPA, FDA, risk assessment, Diagnostic, IVD, laboratory, audits, instrumentation, LEAN, Six Sigma, Kaizen, 5S, IT, Corrective action, preventative action, 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 the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.