Senior Development Quality Specialist
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
Senior 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
Permanent / Full time
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. The candidate shall be required to work cross-functionally with other teams to ensure that all aspects of the LumiraDx Platform are being considered throughout the development and manage these effectively. The candidate shall undertake line management responsibilities for Development Quality Engineers within the team, when appropriate, to ensure that alignment is maintained within the Assay Development Quality Engineer team.
- Line Manager responsibilities
- Creation and management of the IVDR 2017/746 CE marking Technical files
- Update IVDD 98/79/EC Technical Files to comply with IVDR 2017/746
- Manage change control impacting CE marking Technical Files and other regulatory submissions
- Ensure that clinical performance evaluations are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
- Ensure that all Risk Management activities are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
- Support the Assay Development Quality Engineers to ensure that standards are aligned and maintained across all assay development teams
- Support the assay verification and validation activities-reviewing and approving protocols
- Support the transfer of product from R&D to manufacture
- Internal audits, NCs, CAPAs
- 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
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication and leadership, 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.
- Knowledge of IVD Regulation 2017/746
- Experience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities, experience in design transfer to manufacturing is preferred.
- Scientific background, ideally educated to degree level.
- Excellent organizational skills for working on multiple projects.Influence internal project team and external parties to maximize success opportunities.
- Ability to use problem solving tools and methodologies.
- Demonstrable leadership qualities, line management experience is highly desired.
- Experience of pre and post-launch IVD or medical device activities, experience of clinical performance evaluations is desirable.
- Experience of Risk Management in an IVD or Medical Device environment.
- Experience of creating/managing CE marking Technical Files under IVD Directive 98/79/EC.
For further information and to apply for this role, please click APPLY