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 - Validation - based at our site in Alloa
Reporting to the LumiraDx Quality Manager, the successful candidate shall be accountable for the compliance of validation activities associated with new process introduction and changes across all operations departments at the LumiraDx Dumyat site and providing support as required at other sites within LumiraDx Stirling Quality Management System. The successful candidate will be able to lead activities associated with process, equipment and facilities validation and support other quality personnel to achieve required business goals and drive quality improvements. The role will require significant interactions with LumiraDx key stakeholders. Activities such as coordination of validation activities associated with changes / new process introduction, document/process creation, review and approval of documents, monitoring of metrics, and providing support where required to other operations quality activities (eg internal audits; review of quality events) are requirements of this role.
- Subject matter expert for process, equipment and facilities related validation activities providing guidance to QA & Operations departments ensuring a consistent approach across sites and departments
- QA representative on project teams acting as point of contact between project team and QA teams, coordinating QA activities associated with the validation of process / equipment / facilities and providing regular progress updates
- Management of site Master Validation Plan and associated documentation ensuring compliance of documentation to the Stirling QMS
- Facilitate risk management related activities associated with validation ensuring compliance of such activities to the applicable standards and regulations.
- Develop and monitor metrics and KPI’s associated with validation providing inputs to QA team and key stakeholders ensuring visibility of progress and status
- Review and approve change controls as Quality representative on project teams
- Identify opportunities for improvements to validation process and lead the implementation of improvements
- Coach, support and train operations and quality personnel in validation requirements and in the writing of validation documentation
- Prepare and create documents and records for upload on to the document management system
- Review and approve quality events as Quality representative
- Management of 1-3 validation Quality Engineers
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 experience:
- Bachelor’s degree in relevant scientific discipline is strongly preferred, an equivalent level attained through relevant experience may be considered
- Experience of working in a relevant role with a strong quality focus and with knowledge of process and equipment validation
- Experience of post launch IVD or medical device activities in a quality role
- Scientific background
- Ability to use problem solving tools and methodologies
- Excellent organizational skills for working on and prioritizing multiple activities
- Ability to influence internal and external parties to maximise success
- Competent IT skills in EXCEL; POWERPOINT; WORD; and ability to pick up new systems (e.g. document management; ERP systems)
- Good communication skills (verbal & written)
- Experience of working and coordination of activities in multidisciplinary teams
For further information and to apply for this role, please click APPLY