Senior Quality Engineer Operations Instrumentation

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 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 Operations - Instrumentation, based at our site in Alloa

Permanent / Full-time

The Opportunity

Reporting to the LumiraDx Quality Operations Manager, the successful candidate shall be accountable for ensuring that all LumiraDx Platform acceptance, release and servicing activities are compliant with the applicable requirements as defined within the scope of the LumiraDx Stirling Quality Management System.  This role will cover QA Operational responsibilities for Instrumentation activities.  The role holder will be a subject matter expert with respect to device history record creation, maintenance, review and product release.  They will be able to provide QA oversight, guidance and training in all quality operations activities associated with Instrument Operations.  This will include new product / process introduction, improvement projects, batch record review and release, non-conformance and deviation investigations and approvals, KPI and metric generation and reporting. The role holder will be able to lead activities and manage / support quality personnel to achieve required business goals and drive quality improvements.

The Role 

  • Subject matter expert responsible for DMR & DHR creation / maintenance, batch record review and product release for instrumentation
  • Provide QA oversight, guidance and training for all quality activities associated with Instrument Operations ensuring compliance to the applicable LumiraDx procedures
  • QA Representative for review and approval of the following as required, coordinating the QA requirements, providing regular progress updates, and ensuring that risks are fully assessed & material appropriately dispositioned:
    • New product / process introduction
    • Change projects / change requests
    • Quality Events
    • CAPA
    • Deviations
  • KPI / metric generation and reporting providing inputs to site leadership, audits and management review ensuring visibility of progress and status
  • Support other quality personnel to achieve required business goals and drive quality improvements
  • Identify opportunities for improvements and lead the implementation of improvements
  • Prepare and create documents and records for upload on to the document management system
  • Work with key stakeholders to ensure QA requirements are understood and delivered
  • Management of Quality Engineers / Shift Quality Engineers including coaching and training

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:

  • Bachelor’s degree in relevant scientific discipline is strongly preferred  An equivalent level attained through relevant experience may be considered
  • Experience of IVD or medical device Manufacturing/Test/Release/Servicing activities in a Quality Assurance role
  • Strong QA/Scientific/Equipment Engineering 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) and ability to work effectively remotely across regions, time zones and cultures
  • Experience of working and coordination of activities in multidisciplinary teams

 

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

APPLY

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.