Quality Assurance Specialist

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 1,700 employees worldwide.

We 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. 

Opportunity

This role serves as the daily and timely data and document review and approval activities, which are associated with Receiving and incoming material testing, Servicing, Quality Control testing, Production kitting and packaging and Shipping distribution of the company’s Platform products. This position supports the GDP compliance and product disposition of instrument Banks. Review and Approval of executed Batch Records and supporting documentation required for product disposition and release.  The Quality Assurance Specialist role will be located at the LumiraDx, Inc. US-Waltham, MA site. This site is responsible for the review and approval of quality control testing and release documentation of the company’s Platform Products from the facility.

Key Areas of Responsibility

• The production, test, and product release activities such as document/process creation, review and approval of batch records and associated documents. Also, product release and transactions using NetSuite release for shipment.
• Following established procedures to perform structured work assignments and solve operational problems
• Operating within a framework of problem solving / escalation
• Identifying, defining, and addressing problems that are not immediately evident but typically not difficult or complex
• Recommending solutions and making agreed minor changes in systems and processes to solve problems
• Providing investigation support for Corrective Action and Preventive Action (CAPA), Quality Events (QEs), Deviations, Non-conformance Reports (NCRs), and other key processes
• Serve as Data Reviewer to include the creation and management of documentation forming the Batch Records, 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 the QC operations team and other project teams as applicable
• Works closely with all members of the Servicing and QC operations team to guide the teams in the day-to-day batch record submittal and review activities
• Organize and facilitate meetings required to resolve data and record issues to maintain a continuous flow of information leading to release of instruments and products. Ensure compliance of such activities to the applicable standards and regulations
• Coach and support in the enforcement of Good Documentation Practices (GDPs), and in meeting quality requirements and specifications

Essential Skills and Qualifications

• Experience working in an IVD or medical device environment with a strong quality focus and a minimum 7 years’ experience working with IVD product from development through End-of-Life (EOL) would be desirable but not essential
• Demonstrable ability to use problem solving tools and methodologies
• Experience in influencing internal project teams and external parties to maximize success opportunities
• A continuous improvement mindset
• Experience using electronic document management systems and databases
• Bachelor's degree in a relevant discipline

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business.

Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable 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. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.

Please click here to see how we process your data.