Development Quality Engineer
Manor Loan, Stirling
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 currently has over 700 employees worldwide. 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
- 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 Research and Development to manufacture
- Create the technical files for CE marking
- Maintain the technical files
- Internal audits, Non Conformances, Corrective and Preventative Actions
- 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 in an In Vitro Diagnostic or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
- Experience of pre and post launch In Vitro Diagnostic or medical device activities
- Scientific background.
- 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.
- Specific experience
- Scientific degree
- Experience of working on regulatory submissions
For further information and to apply for this role, please click APPLY