Manager Design & Development Quality

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Our client are a medical device diagnostics company that is transforming community-based healthcare. The company manufacture innovative products are being in numerous settings to diagnose and monitor wellness as well as disease. The company is on the market and in development of 30+ tests.

They are looking to add a Manager to the team to lead instrumentation Design & Development Quality. This role is based in Scotland supporting all activities associated with instrumentation and connectivity design & development i.e. software, hardware, mechanical, electrical, connectivity and associated testing defined in the company QMS.

Responsibilities:

• Quality Compliance - Support instrumentation departments to ensure Audit Readiness
• Identify gaps & Opportunities For Improvement and provide quality expertise/training
• Develop and execute appropriate processes for consistent, technical, risk-based decision making
• The Manager Design & Development Quality will monitor quality performance
• Manage QA activities associated with instrumentation design & development, change management, V&V, technical investigations
• Key contact ensuring all QA activities are completed.
• Provide regular project status updates to relevant QA, project and technical teams.
• Escalate any issues on Compliance; Timelines; Resource; Readiness.
• People management - Responsible for hiring, managing, coaching & developing the QA instrumentation team to deliver business goals
• Design & Development Quality Assurance - Manage design quality activities associated with instrumentation.
• The Manager Design & Development Quality will provide advice & support for regulatory submissions acting as interface between RA & technical teams on requirements.
• Change management & design transfer - Provide quality expertise into change management and design transfer associated with instrumentation in compliance.
• Input to project meetings, design and process FMEA's, documentation requirements, quality process updates and alignment with any regulatory requirements.
• Quality events & CAPA - provide quality expertise and guidance into Quality Event & CAPA reports and escalation of high risk issues.
• Process Improvements - work with quality personnel across sites to align on Quality requirements for the business and lead/support quality improvement projects.

Skills/Qualifications:

• Knowledge and experience of working to quality and regulatory standards including ISO13485, FDA21CFR Part 820, ISO 14971
• Awareness of required technical standards e.g. Usability, Medical Device Software, Safety, Cybersecurity, EMC etc.
• Instrument development & Design Quality
• People management
• Degree or equivalent level attained through relevant experience
• Exposure to IVDs would be preferred but not a deal breaker

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales