Quality Manager - Assay Development
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
Quality Manager - Assay Development - this role can be based at either our site in Motherwell or Stirling and will be partly home based with a split between remote and on site working
Reporting to the LumiraDx Development Quality Engineer Manager, the role will 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 role shall be responsible for line managing the development quality engineer group associated with IVD assay development through the R&D phase and the verification and validation phase. They shall be responsible for working 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 role holder shall also work cross-functionally with other teams to ensure that all aspects of the LumiraDx Platform are being considered throughout the development and manage these effectively. In addition, the role-holder shall demonstrate their organizational skills and use problem-solving methodologies to drive a more strategic structured approach within the Development Quality Engineer group to manage the overlapping timelines and demands of the group to launch multiple assays on the LumiraDx Platform.
- Line Manage the Development Quality Engineers within the group
- Creation and management of the IVDR 2017/746 CE marking Technical files
- Update IVDD 98/79/EC Technical Files to comply with IVDR 2017/746
- Manage change control impacting CE marking Technical Files and other regulatory submissions
- Ensure that clinical performance evaluations are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
- Ensure that all Risk Management activities are conducted appropriately to fulfill the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissions
- Support the assay verification and validation activities-reviewing and approving protocols
- Support the transfer of product from R&D to manufacture
- 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
- Introduce new organisational skills and problem-solving methodologies into the Development Quality Engineer group to enable the group to launch multiple successful assays on the LumiraDx Platform
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication and leadership, along with the following skills and experience:
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
- Experience of working in an IVD or medical device environment with a strong quality focus and experience through development and verification and validation activities.
- Experience of product verification and validation.
- Experience of post-launch IVD or medical device activities
- Scientific background, a minimum degree in Biology or Chemistry or related discipline.
- 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.
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