Senior Quality Engineer – Finished Product Supply Chain QA/RC

Location

Remote, EU or UK

Job Type

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

This role can be remote based across Europe and the UK – ideal locations would be Germany or the Netherlands - this role will involve travel across the EU, UK and occasionally global.
Role Description
Reporting to LumiraDx’s Global Supply Chain QARC Leader, the Senior Quality Engineer for Finished Product Supply Chain QA/RC is responsible for maintaining and improving quality and regulatory compliance of finished products and processes within the LumiraDx global supply chain.
Key Roles and Responsibilities
  • Support and control efforts to ensure the quality assurance and regulatory compliance of company products and services for all company locations and distributors within the finished product supply chain.
  • Collaborate with Commercial, Supply Chain, Technical Services and Customer Services to ensure the maintenance of technical, quality and regulatory requirements within the finished product supply chain.
  • Collaborate with global and site QA/RA colleagues to implement and maintain robust QA/RC processes in the finished product supply chain.
  • Support activities to improve finished product supply chain QA/RC performance metrics.
  • Support and control QA/RC improvement projects across finished product supply chain.
  • Support and control escalation management within affiliates and distributors across the finished product supply chain.
  • Participate in and lead audits of 3rd parties, when required, to ensure complaint affiliate and distribution channels.
  • Represent Finished Product Supply Chain QA/RC in external audits or inspections by customers or regulators.
  • May act as the Quality SME for review and approval of Global Supply Chain quality system documents.
  • Support activities to maintain compliance with EU Economic Operator requirements.

Required Experience

Essential skills
  • Knowledge and experience of working to the applicable quality standards and regulatory requirements, including ISO13485, EU IVDR and FDA 21CFR Part 820.
  • Significant experience working in the IVD/medical device industry or similarly regulated environment.
  • Technical background with minimum Bachelor’s degree in a Science, Engineering discipline or Supply Chain, or other degree with relevant industry experience.
  • Ability to use data, problem solving tools and methodologies to drive innovative business solutions.
  • Ability to take a risk-based approach to prioritization and decision making within own work activities.
  • A team player who is able to work with and influence others.
  • Strong interpersonal skills, with an ability to maintain credibility and influence within the organisation, as well as with external stakeholders.
  • Strong presentation and communication skills.
Desirable skills
  • Knowledge and experience in immunoassays and molecular assays.
  • ISO13485 Lead Auditor Certification.
  • Process Excellence or Lean Six Sigma Certification.
  • Proven project management expertise.
  • Experience working within a dynamic and fast paced startup environment.
  • Previous experience working within global supply chain QA/RA.
  • Experience working within teams in a complex matrix environment.

 

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.