Overview
Senior Quality Assurance Engineer / Senior QARA Engineer / Senior Quality Engineer
Reporting to the QARA Manager, the Senior Quality Assurance Engineer supports the effective operation, maintenance, and continuous improvement of the Quality Management System. The role is responsible for ensuring organisational compliance with ISO 13485, FDA 21 CFR 820, and other applicable global quality and regulatory requirements. The Senior Quality Engineer ensures that all required company processes are properly established, implemented, and monitored for ongoing effectiveness, and provides technical quality leadership across the business to maintain high standards of product safety, quality, and regulatory conformity.
NOTE: This position is only open to British / EU / ILR Applicants and offers no sponsorship.
Main Tasks
* Quality and Regulatory: Act as Deputy for the QARA Manager for all matters relating to Quality Assurance.
* Maintain, develop, and improve the Quality Management System in alignment with ISO 13485, FDA 21 CFR 820, and other relevant global regulatory requirements.
* Ensure compliance with national and international standards and legislation.
* Maintain a suitable regulatory framework and associated processes and to update the quality and regulatory processes as necessary in line with new international or country specific legislation.
* Support the QARA Manager in monitoring and ensuring compliance with applicable quality and regulatory requirements.
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