Instrumentation 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
Reporting to the Lumira Dx Quality and Regulatory Director, the successful candidate shall be responsible for the day to day QMS activities associated with IVD instrumentation and software throughout the product lifecycle including the R&D phase the verification and validation phase, manufacturing and product release. Activities such as document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day use of the quality management system and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the lifecycle.
Key Roles and Responsibilities
- Quality representative for project teams throughout product lifecycle and product realization activities
- Creation and management of documentation forming the Design History File and Device Master Record.
- Assess, control and coordinate changes to Design History File and Device Master Record.
- Coach and support in the writing of design requirements and specifications.
- Coach and support in the writing of Verification and Validation plans and protocols
- Creation of traceability matrices.
- Organize, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.
- Ensure compliance of documentation for design partners (and suppliers) within the supply chain.
- Support supplier approval and monitoring activities.
- Prepare and create documents and records for upload on to GAS.
- Review and approve as Quality representative on project teams and QMS.
- Review and approve Device History Records and final product release.
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, ISO62304, FDA 21CFR Part 820.
- Experience of working in an IVD or medical device environment with a strong quality focus and through development and verification and validation activities, ideally with a focus on software
- Knowledge and experience in medical device hardware and software projects
- 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, science degree desired.
- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)
For further information and to apply for this role, please click APPLY