Senior Quality Engineer - Risk Management
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 Quality Engineer – Risk Management
This role can be remote based within the UK with travel to our sites in Scotland as required
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 primarily be responsible for managing the Risk Management activities, both pre and post market, for the LumiraDx Platform and ensuring that procedures followed are in compliance with ISO 14971 Medical devices. Application of risk management to medical devices.
Key Roles and Responsibilities
- Ensuring that all Risk Management Procedures are conducted in compliance with ISO 14971 Medical devices. Application of risk management to medical devices
- Ensuring 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
- Ensure that a robust process is in place so that all Post Market surveillance data is integrated back into the Risk Management activities
- Support the transfer of product from R&D to manufacture
- Support the creation of the technical files for CE marking
- Internal audits, NCs, CAPAs
- Working with the assay development teams to ensure that risk management activities are initiated early within the design and development processes and drive the design process throughout the whole lifecycle of the product
- 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
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
- Experience of Risk Management in an IVD or Medical Device environment
- 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 of pre and post launch IVD 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.
- Scientific degree
- Experience of working on regulatory submissions
For further information and to apply for this role, please click APPLY