Quality Assurance Manager Full Time

Stirling, Stirlingshire
Hays
Medical device manufacturers are looking for a Quality Assurance Manager with design capabilities.

This key role is responsibility for managing instrumentation (hardware and software) and connectivity design & development quality compliance.
Reporting to the Senior Director Quality (Operations and Instrument Design & Development), this role is primarily based at the Maxim site while working with key stakeholders. Support all activities associated with instrumentation and connectivity design & development ie software, hardware, mechanical, electrical, connectivity and associated testing requirements. QMS is a key aspect of this role, ensuring that an Audit Ready Everyday culture is upheld within the departments supported. The job holder will be responsible for QA review and approval of all instrumentation design changes.

Essential Experience:

Relevant experience of instrument design and development and manufacturing quality process
Relevant experience of medical device and / or in vitro diagnostics quality processes including design review, change management, design transfer, risk management, non conformance management, CAPA, problem-solving tools
Experience in people management
Experience of working and coordination of activities across multidisciplinary teams
Competent IT skills in Excel, PowerPoint, Word; and ability to pick up new systems (e.g., document management; ERP systems)
Quality / Regulatory Compliance

Sound knowledge and experience of working to the appropriate quality and regulatory standards, including ISO13485, FDA21CFR Part 820, ISO 14971
Awareness of required technical standards ISO 62366 (Usability); ISO 62304 (Medical Device Software); ISO 61010 (Safety Requirements); UL 2900 / ISO 27001 (Cybersecurity); IEC 61326 (EMC)
Knowledge of IVD Regulation 2017/746 in relation to instrument development
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