QA Manager - Medical, FDA

We are currently looking for a Quality Assurance Manager to join our client who specialise in providing software systems to the medical industry.

This role will be on a permanent basis in Burton on Trent. Hybrid, on site/remote working available.

Salary up to £55,000 plus Benefits

Responsible for all aspects of the clients Quality Management System (QMS) and Information Security Management System (ISMS). You will ensure these systems are aligned to required ISO Standards, and that where applicable, the QMS is followed as part of product development.

You will hold professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices, with a proven track record in regulatory submissions and ISO certifications.

You will be responsible for leading a quality team, and the organisation as it strives to deliver quality software within the In Vitro Diagnostic Industry
 

Key skills and experiences required:

• 3 years’ experience of in-depth software quality management in a professional environment.
• Prior experience within the medical sector or a high regulatory environment
• Management of a Quality System to a recognised standard.
• Experience in regulatory submissions
• Experience in stakeholder management and team leadership
• Audit experienced/trained
• Formally educated to degree level in an IT based subject preferred but not essential.

• Knowledge of FDA and FDA requirements in relation to software
• Knowledge of IVDR Regulation 2017/746
• Knowledge of UK Medical Device Regulation
• Knowledge of ISO 13485, 14971, 27001 and standards IEC 62304 62375
• Ability to convert regulatory requirements into relevant quality management processes and work instructions