Development Quality Engineer

Location

Manor Loan, Stirling

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

Opportunity:
Reporting to the Lumira Dx Quality and Regulatory Director, the successful candidate shall be responsible for the day to day Quality Management System activities associated with In Vitro Diagnostic instrumentation and software throughout the product lifecycle including the Research and Development phase the verification and validation phase, manufacturing and product release. Activities such as document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day use of the quality management system and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the lifecycle.
Key Roles and Responsibilities:
  • Work with individual assay development teams as a quality and regulatory support
  • Work with the Technical Leaders and Project Managers to maintain quality throughout the Design and Development process
  • Organise and facilitate design reviews
  • Facilitate the risk management activities for the assays and the overall platform
  • Support the assay verification and validation activities-reviewing and approving protocols
  • Support the transfer of product from Research and Development to manufacture
  • Create the technical files for CE marking
  • Maintain the technical files
  • Internal audits, Non Conformances, Corrective and Preventative Actions

Required Experience

Essential skills:
  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
  • Experience of risk management activities
  • Experience of working in an In Vitro Diagnostic or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
  • Experience of pre and post launch In Vitro Diagnostic or medical device activities
  • Scientific background.
  • Excellent organizational skills for working on multiple projects.
  • Ability to use problem solving tools and methodologies.
  • Influence internal project team and external parties to maximize success opportunities.
Desirable skills:
  • Specific experience
  • Scientific degree
  • Experience of working on regulatory submissions

 

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.