Instrumentation Design Manager

1 month ago


Glasgow, Glasgow City, United Kingdom LumiraDx Full time
Job Description

This key role has responsibility for managing instrumentation (hardware and software) and connectivity design & development quality compliance, ensuring compliance of all instrumentation design & development activities to the required standards and procedures as defined in LumiraDx QMS.

Responsibilities:
  • Quality Compliance - Support instrumentation departments to ensure Audit Ready Every day and compliant with LumiraDx QMS, identifying gaps & Opportunities For Improvement (OFI) and providing quality expertise, guidance and training to address.
  • Project management - Management of all QA activities associated with instrumentation design & development, change management, V&V, technical investigations and department QA support, interfacing with key stakeholders (technical, QA & RA) acting as key contact ensuring all QA activities are completed.
  • People management – Responsible for hiring, managing, coaching & developing the QA instrumentation team to deliver business goals, planning and leading 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.
  • Design & Development Quality Assurance – Manage all design quality activities associated with instrumentation, ensuring 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.
  • Change management & design transfer - Provide quality expertise into change management and design transfer associated with instrumentation in compliance with LumiraDx procedures, including 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.
Qualifications:
  • 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).
  • Degree level educated within a relevant discipline.


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