- Remote UK Based, Occasional travel to Geneva, Switzerland
- Leading products across multiple therapeautic areas: Ortho and Gastro
- Exceptional Global Reach. Strong progression and growth
SRG partner with a small Medical Device company based in Geneva, Switzerland. Due to further expansion, a QARA Manager is required on a permanent basis. You will be home based within the UK, and willing to travel to Geneva on a monthly basis.
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.
- 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.
- Clinical Evaluation
- MDD Medical Device Risk Management
- MDD Technical File development and administration
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
- Analytically minded, strong problem solving skills
- Confidence to manage a small team, lead and motivate others, project-management skills.
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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