Development Quality Engineer

Quality Assurance · Manor Loan, Stirling
Department Quality Assurance
Employment Type Permanent
Minimum Experience Mid-level
Compensation Competitive

Development Quality Engineer / Specialist - this role can be based at either our site in Motherwell or Stirling and will be partly home based with a split between remote and on site working


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.

 

The Opportunity


Reporting to the LumiraDx Development Quality Engineer Manager, the successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases. 

The candidate shall work with project teams to support in the design and development process and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle. Activities shall include risk management, generation document/process creation, review and approval of V&V documents and creation of Technical Files for regulatory submissions.


The Role

  • Work with individual assay development teams as a quality and regulatory support
  • Work with the Technical Leaders and Project Managers to maintain quality throughout the Design and Development process
  • Organise and facilitate design reviews
  • Facilitate the risk management activities for the assays and the overall platform
  • Support the assay verification and validation activities-reviewing and approving protocols
  • Support the transfer of product from R&D to manufacture
  • Create the technical files for CE marking
  • Maintain the technical files
  • Internal audits, NCs, CAPAs


About You


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 skills and experience:


  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.  
  • Experience of Risk Management activities, experience of working on regulatory submissions is desired.
  • Experience of working in an IVD or medical device environment ideally with a strong quality and regulatory focus and experience through development and verification and validation activities
  • Scientific background, ideally educated to degree level in a scientific discipline.
  • Experience of pre and post-launch IVD or medical device activities
  • Excellent organizational skills for working on multiple projects.
  • Ability to use problem solving tools and methodologies.
  • Influence internal project team and external parties to maximize success opportunities.

 

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

Your application was submitted successfully.

  • Location
    Manor Loan, Stirling
  • Department
    Quality Assurance
  • Employment Type
    Permanent
  • Minimum Experience
    Mid-level
  • Compensation
    Competitive