Quality Engineer

Location

Alloa, UK

Job Type

Permanent

Company Overview

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 currently has over 700 employees worldwide. 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

The successful candidate shall be responsible for the day to day QMS activities associated with the production of IVD sensors (assays) and instrumentation with emphasis on providing QA input to manufacturing support, supply chain activities, process validation, complaint investigations and/or product release. Activities such as document/process creation, review and approval of documents, batch release and internal audits are requirements of this role. Effective working with other LumiraDx quality assurance, technical, production, engineering, customer services and supply chain personnel will be required ensuring day to day use of the quality management system in line with the requirements of ISO 13485:2016 and CFR 21 Part 820.
Key Roles and Responsibilities
  • Providing quality advice and support to other departments within the LumiraDx Stirling organization
  • QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues
  • QA review of records associated with commercial and/or validation batches including the collation and archiving of all relevant batch records as part of Device History Records
  • Update and maintain Device Master Records
  • Execution of internal audits
  • Collation and provision of data for external audits
  • Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
  • Collation of data to support the generation of Quality Metrics and KPI’s
  • Support supplier approval and monitoring activities including supplier audits
  • 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

Essential skills
  • Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry
  • Experience of working in a relevant role with a strong quality focus and with a minimum of 2 years’ experience
  • Scientific background
  • Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
  • Excellent attention to detail
  • Good team worker
  • Excellent organizational skills for working on and prioritizing multiple activities
  • Ability to use problem-solving tools and methodologies
Desirable skills
  • Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP
  • Experience of post-launch IVD or medical device activities in a quality role
  • Specific relevant experience eg complaint investigation, batch review/release, process validation
  • Degree preferred
  • Trained auditor
  • Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)

 

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process 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.