Requirements

Required experience
Between 3 and 5 years
Required language knowledge
English French German
Required skills
QA Compliance Medical Devices Switzerland MEDICAL DEVICES SWITZERLAND compliance medical devices switzerland gmp FDA Medical devices LEAN SIX Sigma Quality Assurance ISO 13485 CAPA GMP GMP laboratory Switzerland IVD Laboratory Quality assurance Audits Quality Engineer ISO 9001 quality engineer instrumentation quality assurance six sigma diagnostic Diagnostic lean ISO 14971 Six Sigma fda COMPLIANCE risk assessment audits

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Quality Control / Processes Management / Project Managemen... Engineer / R & D Technical-commercial Testing / Audit / Release Mana...

Description

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, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and ArbeitsZeugnisse (work references).

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 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.

NonStop Consulting
Sep 6, 2022

Contact info

NonStop Consulting
Andrew Boroky
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Not available