Senior Development Quality Engineer
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 remote based across the UK with some travel to our sites in Scotland when required
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 support the Development Quality Engineers to ensure that alignment is maintained within the Assay Development Quality Engineer team.
- 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 fulfil 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 fulfil 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 problem solving, 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 creating/managing CE marking Technical Files under IVD Directive 98/79/EC
- 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.
- 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.
For further information and to apply for this role, please click APPLY