Senior 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.
Reporting to the LumiraDx Quality Manager, the successful candidate shall be accountable for maintaining compliance of the LumiraDx Stirling Quality Management System and providing support to local departments to ensure the requirements of ISO 13485:2016 and CFR 21 Part 820 are implemented in full. The successful candidate will be a subject matter expert able to lead activities and manage other qualified personnel to achieve required business goals and drive quality improvements. The role will require significant interactions with LumiraDx key stakeholders and on occasion with external parties (eg suppliers, external auditors). Activities such as document/process creation, review and approval of documents, batch release and internal audits are requirements of this role.
Key Roles and Responsibilities
• Quality representative for one or more departments within LumiraDx at Stirling providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
• Coordination of QA activities associated with QMS changes; batch release; customer feedback (including complaint) investigations; process validation and / or supplier monitoring to meet the wider business goals.
• Organize, host and facilitate risk management related activities and ensure compliance of such activities to the applicable standards and regulations.
• Management of quality personnel
• Monitoring of quality KPI’s and input to management review
• Execution of internal and supplier audits
• Support and input to external audits
• Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
• Prepare and create documents and records for upload on to the document management system
• Review and approve change controls as Quality representative on project teams and QMS
• Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820, MDSAP
• Experience of working in a relevant role with a strong quality focus
• Experience of post-launch IVD or medical device activities in a quality role
• Scientific background
• Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
• Specific relevant experience with a high level of knowledge eg complaint investigation, batch review/release, process validation
• Excellent organizational skills for working on and prioritizing multiple activities
• Ability to use problem-solving tools and methodologies
• Ability to influence internal and external parties to maximise success
• Good communication skills
• Qualification to degree level
• People management experience
• Knowledge and experience of MDSAP
• Trained auditor
• Continual Improvement Training (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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