Quality Director QMS
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
Quality Director QMS – this is a multi-site role and will be required to travel across our sites in Central Scotland - Alloa, Glasgow and Bathgate
Reporting to the Site VP for LumiraDx Quality and Regulatory, the successful candidate shall be responsible for the Quality management systems of the business across multiple sites. This role will work closely with Quality and Regulatory Directors across the LumiraDx business to drive improvements and implement requirements to meet global business needs.
Activities such as the improvement and maintenance of the accredited QMS and Supplier and Audit functions are included within this role. This role will be responsible for line management of Quality Managers and Senior Quality Engineers.
Key Roles and Responsibilities
- Work at strategic level to Support One LumiraDx ethos across the business.
- Understand the LumiraDx business and make decisions that affect multiple sites, assessing impact of quality process across multiple sites.
- Create and manage metrics for QMS
- Lead quality management system processes and accreditation
- Lead Inspection Readiness/Audit Ready Everyday programme
- Work with Quality Ops director and Regulatory compliance team to Update QMS to include other global QMS requirements including WHO/CMDCAS as required for global markets
- Train the wider LumiraDx organization in the importance of quality management system
- Work with other LumiraDx organizations to align on Quality for the LumiraDx business
- Lead external audits for global certification purposes.
- Accountable for Supplier and Distribution compliance
- Accountable for Management review
- Role model quality
- 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, develop and leads a multi-site Quality team
- Coaching and mentors 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 High volume manufacturing
- Experience in Design and Development
- Experience of MDSAP/WHO/CMDCAS
- Experience in Risk Management
For further information and to apply for this role, please click APPLY