Senior Manager, Data

2 weeks ago

Glasgow, United Kingdom LumiraDx International Limited Full time

Manager, Instrumentation, Design & Development Quality
Full-time
Contract Type: Permanent LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA and is supported by a global sales network. This 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. 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 / metrics
Project management - Management of all QA activities associated with instrumentation design & development, change management, V&V, technical investigations and department QA support. Provide data to other departments to enable effective planning of priorities. Provide regular project status updates to relevant QA, project and technical teams. People 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.
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
Competent IT skills in Excel, PowerPoint, Word; document management; Recruitment Process: t LumiraDx, diversity and inclusion are part of who we are. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business Please note, if you wish to submit an application for this role, please consider the following information: Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance. Please clickhere to seehow we process your data. #

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