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 Operations - Assay, based at our site in Alloa
Permanent / Full-time
Reporting to the LumiraDx Quality Operations Manager the successful candidate shall be accountable for ensuring that LumiraDx batch release and associated activities are compliant with all applicable requirements as defined within the scope of the LumiraDx Stirling Quality Management System. The role will cover QA Operational responsibilities for assay activities. The role holder will be a subject matter expert with respect to Device History Record creation, maintenance, review and product release, In role they will be able to provide QA oversight, guidance and training in all quality operations activities associated with Assay Operations. This will include new product / process introduction, improvement projects, batch record review and release, non-conformance and deviation investigations and approvals, KPI and metric generation and reporting. The role holder will be able to lead activities and manage / support other quality personnel to achieve required business goals and drive quality improvements.
- Subject matter expert responsible for DMR & DHR creation / maintenance, batch record review and product release for assays
- Provide QA over-sight, guidance and training for all quality assurance activities associated with Assay Production and Testing ensuring compliance to the applicable LumiraDx procedures
- QA Representative for review and approval of the following as required, coordinating the QA requirements, providing regular progress updates, and ensuring that risks are fully assessed & material appropriately dispositioned:
- New product / process introduction
- Change projects / change requests
- Quality Events
- KPI / metric generation and reporting providing inputs to site leadership, audits and management review ensuring visibility of progress and status
- Support other quality personnel to achieve required business goals and drive quality improvements.
- Identify opportunities for process improvements and lead the implementation of improvements
- Prepare and create documents and records for upload to the document management system
- Work with key stakeholders to ensure QA requirements are understood and delivered
- Management of Quality Engineers / Shift Quality Engineers including coaching and training
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:
- Bachelor’s degree in relevant scientific discipline is strongly preferred An equivalent level attained through relevant experience may be considered
- Experience of working in a relevant role with a strong quality focus
- Specific relevant experience with a high level of knowledge e.g. batch review/release, nonconformance management, change management
- Experience of post launch IVD or medical device activities in a quality role
- Scientific background
- Ability to use problem solving tools and methodologies
- Excellent organizational skills for working on and prioritizing multiple activities
- Ability to influence internal and external parties to maximise success
- Competent IT skills in EXCEL; POWERPOINT; WORD; and ability to pick up new systems (e.g. document management; ERP systems)
- Good communication skills (verbal & written)
- Experience of working and coordination of activities in multidisciplinary teams
For further information and to apply for this role, please click APPLY