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
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