Role Description
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
Required Experience
About You:
Essential skills
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)
Self-starter
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
Desirable 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)
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