Senior Quality Engineer Support and Product Release

Location

Bathgate, 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 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 - Support & Product Release - Bathgate

The Opportunity

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 in product release as well as providing support to operational activities.  Will be 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).

The Role 

  • Quality representative for one or more departments within LumiraDx providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
  • Ensure quality and regulatory compliance is maintained for activities at the Bathgate facility including all shipments
  • QMS development & support work with QMS team to implement improvements / QMS system changes
  • Work with key stakeholders (supply chain, fulfilment, cartoning) to ensure Audit Ready Every Day
  • Responsible for DHR Review and final product release of LumiraDx Stirling product instruments & strips
  • Timely resolution and approval of non-conformances and CAPA at Bathgate facility
  • Review, approval and oversight of planned deviations at Bathgate facility
  • Line management for Shift Quality Engineers
  • Produce & maintain meaningful metrics
  • Drive process improvements via CAPA

Required Experience

About You:

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:

  • Experience of working in a relevant role with a strong quality focus, particularly around product release and support of operations
  • Experience of post-launch activities in a quality role within IVD, medical device or pharmaceutical environment
  • Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
  • 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
  • People management experience is desirable

 

For further information and to apply for this role, please click APPLY

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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.