Senior Quality Engineer – Finished Product Supply Chain QA/RC
Remote, EU or UK
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
- 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.
- 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.
- 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.
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