Manager, Instrumentation, Design & Development Quality

Job DescriptionThis key role has responsibility for managing instrumentation (hardware and software) and connectivity design & development quality compliance.Scope: 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 across the Stirling Campus and Waltham sites to support all activities associated with instrumentation and connectivity design & development ie software, hardware, mechanical, electrical, connectivity and associated testing requirements. Ensuring compliance of all instrumentation design & development activities to the required standards and procedures as defined in LumiraDx 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.Responsibilities:Quality Compliance - Support instrumentation departments to ensure Audit Ready Every day and compliant with LumiraDx QMS. Role model a quality compliance culture at all times. Identify gaps & Opportunities For Improvement (OFI) and provide quality expertise, guidance and training to address. Support internal reviews and both internal and external audits by providing required quality inputs. Use the Quality Management System to develop and execute the appropriate processes for consistent, technical, risk-based decision making. Monitor quality performance via Key Performance Indicators / metricsProject management - Management of all QA activities associated with instrumentation design & development, change management, V&V, technical investigations and department QA support. Interface with key stakeholders (technical, QA & RA) acting as key contact ensuring all QA activities are completed. Provide data to other departments to enable effective planning of priorities. Provide regular project status updates to relevant QA, project and technical teams. Escalate any issues on Compliance; Timelines; Resource; Readiness. Demonstrate responsiveness to business needs and motivation of diverse, cross-functional teams, including influencing both internal and external members to achieve positive resultsPeople management – Responsible for hiring, managing, coaching & developing the QA instrumentation team to deliver business goals. Plan and lead the activities of team and self, ensuring that all quality activities associated with instrumentation design & development are completed in a compliant, timely and effective manner and that business priorities are met. Establish the quality plans, schedules and identify & implement improved ways of working within the QA team.Design & Development Quality Assurance – Manage all design quality activities associated with instrumentation. Ensure instrumentation Design & Development activities are compliant with LumiraDx QMS and meet the required regulatory standards. Accountable for instrumentation Design History File ensuring maintained and accurate. 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 with LumiraDx procedures. This includes input to project meetings, design and process FMEA’s, instrumentation department documentation requirements, quality process updates and ensuring alignment with any regulatory requirements specified by Regulatory Affairs.Quality events & CAPA - provide quality expertise and guidance into Quality Event & CAPA reports (investigations, actions, product disposition, containment and effectiveness) ensuring compliance with LumiraDx procedures, timely and effective QA feedback to departments and escalation of high risk issues.Process Improvements – work with quality personnel across sites to align on Quality requirements for the LumiraDx business and lead / support quality improvement projects.QualificationsEssential Experience:Relevant experience of instrument design and development and manufacturing quality processRelevant 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 toolsExperience in people managementExperience of working and coordination of activities across multidisciplinary teamsCompetent IT skills in Excel, PowerPoint, Word; and ability to pick up new systems (e.g., document management; ERP systems)Essential Qualifications:Degree level educated within a relevant discipline.