Quality Management Systems (QMS) Director

Location

Scotland, UK

Job Type

Company Overview

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 Management Systems (QMS) Director

This is a multi-site role and can be based at any of our sites in Central Scotland - Alloa, Glasgow and Bathgate - will be required to travel across these sites as well as some UK and possibly international travel

The Opportunity

Reporting to the VP – Global QA/RA, the successful candidate shall be responsible for the Quality management systems  of the business across multiple sites (7 in total across UK and US). 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.

The Role

  • 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
  • Manage quality management system processes and accreditation
  • Manage 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
  • Manage 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, develops and leads a multi site Quality team
  • Coaching and mentors to develop high performing teams

Required Experience

About You

We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in leadership along with the following experience:

  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.  
  • Experience of working in an IVD or medical device environment or similar with relevant experience at Quality Manager level.
  • Previous experience of aligning global company quality management systems Experience of managing and developing a high performing team
  • Scientific or Quality  background, minimum degree level.
  • Influence internal team and external parties to maximize success opportunities.
  • Ability to use problem solving tools and methodologies.
  • Experience of Supplier and Distributor Controls
  • Previous experience of managing multiple sites simultaneously
  • Experience of being designated site Management Representative
  • Experience of managing and hosting competent authority, notified body and customer audits.

 

For further information and to apply for this role, please click APPLY

APPLY

Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process 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.