Instrumentation 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 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
- 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 protocol.
- 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, FDA 21CFR Part 820.
- Experience of working in an In Vitro Diagnostic or medical device environment with a strong quality focus and at minimum 2 years’ experience through development and verification and validation activities.
- Knowledge and experience in electromechanical 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