Quality Manager (Operations)
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
Reporting to the Quality Director (Operations), the role is responsible for all Operational Quality requirements at the Bathgate site.
This role is accountable for ensuring compliance at a site level to the LumiraDx Quality Management System (including requirements of ISO 13485:2016/CFR 21 Part 820 /MDSAP and other country specific conditions). This will include accountability for compliant release of product, providing quality expertise to other internal and external key stakeholders, and the identification and implementation of local QMS improvements. This role will be responsible for line management of a team of day and shift Quality Engineers.
Key Roles and Responsibilities
- Demonstrate and lead a quality compliance culture setting the required quality standards for product and processes
- Identify and drive continuous improvement to local quality systems / processes and monitor / communicate via monthly quality KPI’s
- Manage the site QMS processes and infrastructure to ensure continued compliance and fitness for purpose for the business (including, but not limited to, internal audit programme, site quality event process, management of non-conforming product and management review)
- Manage the release of product compliantly and in line with business timelines
- Work with other operational departments to ensure that products are manufactured and tested to the required quality standards
- Communicate and coordinate significant quality issues including completing impact assessments and decisions on product disposition
- Work with other LumiraDx sites to align on Quality for the LumiraDx business
- Manage and host external audits for global certification purposes
- Day to day implementation of risk management for facility and process
- Provide quality expertise into the review, approval and impact assessment of changes
- Collaborates with all functions in the organisation as well as own function to ensure Quality Assurance is integrated into all systems and processes across the organisation
- Collaborate effectively with other function to deliver overall company vision and strategic goals
- Provide expertise and guidance on all aspects of how Quality Assurance integrates with other functions to achieve the goals of the business
- Grow, develops and leads a Quality team
- Coaching and mentor Senior Quality Engineers to develop high performing teams
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
- Experience of managing and hosting competent authority, notified body and customer audits.
- Experience of working in an IVD or medical device environment or similar with minimum 5 years’ experience at Quality Manager level.
- Previous experience of managing product release of medical device/IVD products.
- Previous experience identifying and implementing quality improvements at a site level
- Previous experience in a quality management role
- Experience of managing and developing a high performing team
- Experience of manufacturing and post launch IVD or medical device activities
- Scientific background, minimum degree in Biology or Chemistry.
- Ability to use problem solving tools and methodologies.
- Influence internal team and external parties to maximize success opportunities.
- Knowledge and experience in immunoassays and molecular assays
- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)
- Experience in people development
- Previous experience of managing multiple sites simultaneously
For further information and to apply for this role, please click APPLY