Quality Director - QMS

Quality Assurance · Glasgow, North Lanarkshire
Department Quality Assurance
Employment Type Permanent
Minimum Experience Manager/Supervisor
Compensation Competitive

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

 

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 Description

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


About You:


Essential skills

  • 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 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.

 

Desirable skills

  • Knowledge and experience in High volume manufacturing
  • Experience in Design and Development
  • Experience of MDSAP/WHO/CMDCAS
  • Experience in Risk Management

 

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business.


Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.

LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.

Thank You

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  • Location
    Glasgow, North Lanarkshire
  • Department
    Quality Assurance
  • Employment Type
    Permanent
  • Minimum Experience
    Manager/Supervisor
  • Compensation
    Competitive