Senior Quality Engineer

Location

Waltham, US

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

Role Description

The Senior Quality Assurance Engineer role will be located at the LumiraDx, Inc. US-Waltham, MA site. This site currently is responsible for the review and approval of quality control testing and release documentation of the company’s Platform Products from the facility. This role will also oversee the documentation of instrumentation development and software systems in support of the Platform Product.

This role serves as the day-to-day overseer of the Quality Management System (QMS) activities, which are associated with development, test methodology and instrumentation of the company’s Platform products throughout the product lifecycle

Key Roles and Responsibilities

  • The production, test, and product release activities such as document/process creation, review and approval of batch records and associated documents
  • The review and approval of data in support of the Validation Master Plan, including the Verification and Validation (V&V) of processes, equipment, and software systems as required
  • Providing investigation support for Corrective Action and Preventive Action (CAPA), Quality Events (QEs), Deviations, Non-conformance Reports (NCRs), and other key processes
  • Support supplier approval and monitoring activities
  • Ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the lifecycle
  • Serve as Document Administrator to include the creation and management of documentation forming the Design History File and Device Master Record for the US-Waltham site
  • Support internal, regulatory, and customer audits as required
  • Review and approve documents and processes as Quality Representative on project teams and within the QMS
  • Work closely with all project teams to guide the teams in the day-to-day use of the QMS
  • Organize, host, and facilitate risk management-related activities with the project teams and ensure compliance of such activities to the applicable standards and regulations
  • Coach and support in the writing of quality requirements and specifications
  • Coach and support in the writing of V&V validation plans, protocols, and reports 

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:

Essential skills

  • Knowledge and experience working to the appropriate quality and regulatory standards including ISO13485 and FDA 21 CFR Part 820
  • Ability to use problem solving tools and methodologies
  • Influence internal project team and external parties to maximize success opportunities
  • Continual Improvement mindset 
  • Experience using electronic document management systems and databases

Desirable

  • Experience working in an IVD or medical device environment with a strong quality focus and experience working with IVD product from development through End-of-Life (EOL)
  • IVD instrumentation experience
  • Knowledge and experience in electromechanical medical device hardware and software projects
  • Six Sigma Green Belt Certification
  • Experience of post-launch IVD or medical device activities including minimum of 2 products

 

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.