Senior Quality Engineer Instrument Release
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, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Senior Quality Engineer - Instrument Release - Alloa
Reporting to the LumiraDx Quality Manager, the successful candidate shall be accountable for maintaining compliance of the LumiraDx Stirling Quality Management System and providing support to local departments to ensure the requirements of ISO 13485:2016 and CFR 21 Part 820 are implemented in full.
The successful candidate will be a subject matter expert in instrument release and will be able to lead activities and manage other qualified personnel to achieve required business goals and drive quality improvements. The role will require significant interactions with LumiraDx key stakeholders and on occasion with external parties (eg suppliers, external auditors).
- Quality representative for one or more departments within LumiraDx providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
- DHR & Product release of instrument batch QC records
- QMS development & support work with QMS & QA instrument teams to implement improvements / QMS system changes
- Timely resolution and approval of instrument related non-conformances and CAPA
- Liaise directly with instrument manufacturer on non-conformances, planed deviations & changes
- Support Instrumentation Engineering & QC to ensure compliance is maintained
- Line management for Quality Engineer
- Produce & maintain meaningful metrics
- Manage the Material Review Board for instruments
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:
- Experience of working in a relevant role with a strong quality focus, particularly in product release
- Experience of post-launch activities in a quality role within IVD, medical device or pharmaceutical environment
- Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
- Excellent organizational skills for working on and prioritizing multiple activities
- Ability to use problem-solving tools and methodologies
- Ability to influence internal and external parties to maximise success
- People management experience is desirable
For further information and to apply for this role, please click APPLY