Senior Quality Engineer - Risk Management

Senior Quality Engineer – Risk Management

This role will ideally be based at our Stirling site but we are open to the candidate being remote based as long as you are willing to travel to site as required

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 Description

Reporting to the LumiraDx Development Quality Engineer Manager, the successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases.

The candidate shall work with project teams to support in the design and development process and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle. The candidate shall primarily be responsible for managing the Risk Management activities, both pre and post market, for the LumiraDx Platform and ensuring that procedures followed are in compliance with ISO 14971 Medical devices. Application of risk management to medical devices.

Key Roles and Responsibilities

• Ensuring that all Risk Management Procedures are conducted in compliance with ISO 14971 Medical devices. Application of risk management to medical devices
• Ensuring that all Risk Management activities are conducted appropriately to fulfil the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
• Ensure that a robust process is in place so that all Post Market surveillance data is integrated back into the Risk Management activities
• Support the transfer of product from R&D to manufacture
• Support the creation of the technical files for CE marking
• Internal audits, NCs, CAPAs
• Working with the assay development teams to ensure that risk management activities are initiated early within the design and development processes and drive the design process throughout the whole lifecycle of the product
• 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

Required skills & 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 in an IVD or Medical Device environment
• Experience of working in an IVD 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 IVD 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

• Scientific degree
• Experience of working on regulatory submissions

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.