QA/RA Manager

QA/RA Manager
  • CHF 100'000 - CHF 120'000 per Annum
    ANNUM
  • Permanent
  • Switzerland Geneva Switzerland 1207
Job Ref: J36498
Sector: Clinical
Sub-sector: Medical Devices
Date Added: 24 June 2020
QA/RA Manager - Geneva, Switzerland - Medical Device

QA/RA Manager - Geneva, Switzerland - Medical DeviceSRG are currently recruiting for a QA/RA Manager to join a small Medical Device company based in Geneva, Switzerland on a permanent basis at a salary of circa 100 - 120 CHF, depending on experience. Working with medical device products focused around orthopedic joint recovery and gastrontology illness, you will manage quality and ensure that the relevant quality and regulatory requirements and are met. Obtain and maintain authorisation to market medical devices in countries world-wide.ACTIVITIES* Oversee the department's management and promotion of the Quality System; care for its on-going improvement.* Report to Management Representive on the performance of the quality management system and any need for improvement.* Ensure that the company's Quality Policy and set objectives are met; plan and implement monitoring, measurement, analysis and improvement of quality performances of the organisation.* Ensure regular update and management of the Quality Manual.* Set up quality strategy, quality objectives & guidelines (e.g. Critical Control Points, Lowest and Highest Acceptance Levels).* Implement requirements, both internally and towards external partners and suppliers.* Provide technical & quality support to sub-contractors and verify that standards are met.* Take part in the design and realisation/industrialisation of the products (choice of technical means, quality strategy, process monitoring, etc.)* Manage internal and external audits.* Ensure that nonconformities and vigilance cases (complaints/vigilance events, withdrawals, recalls etc.) are handled promptly and correctly.* Raise necessary changes to management representive and take appropriate corrective and preventive actions.* Release batches of medical devices for sale.* Organise an annual Quality Management Review.* Providing the necessary training to ensure employees understand QMS.Qualifications and Skills:A degree in life science-related discipline and 5 years' relevant experience in Senior QA/RA level responsibilities.Understanding of both legal and scientific matters, the ability to grasp new concepts quickly and to assimilate and evaluate scientific data, analytical and problem-solving skills, written and oral communication skills, attention to detail, strong negotiation skills, IT skills, particularly in relation to using databases and familiarity with commercial software, the ability to work under pressure and to strict deadlines, the confidence to report to management, team-working skills and the ability to lead and motivate others, project-management skills, integrity and a professional approach to work, tact and diplomacy, an awareness of the legislation governing the approval of products.For more information, please call Laith Mustafa on 0161 868 2231 or email laith.mustafa@srg.co.uk

SRGTalent
24/07/2020 12:44:01
CHF 100000 100000
Contact Consultant:
Laith Mustafa

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