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
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. Activities shall include risk management, generation document/process creation, review and approval of V&V documents and creation of Technical Files for regulatory submissions.
- 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
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.
For further information and to apply for this role, please click APPLY