QA RA Engineer
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
Permanent / Full time – this role can be partly remote based but will require regular travel to siteThe Opportunity
Reporting to the Lumira Dx Care Solutions QA/RA Lead, the QA/RA Engineer will be responsible for the day to day QMS activities and supporting teams in the design, development, manufacture, and support of software for the healthcare industry.
The main purpose of the role is to act as the Quality and Regulatory representative in the day to day QMS activities and working with all project teams to guide the teams in the use of the quality management system and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the lifecycle.
- Prepare and create documents and records for upload onto the electronic QMS system.
- Coach and support in the writing of design requirements and specifications.
- Assess, control and coordinate changes to Design History File and Device Master Record.
- Review and approve as quality representative on project teams and QMS.
- Review and approve Device History Records and final product release.
- Support risk management related activities and design reviews.
- Support 3rd party audits.
- Conduct and support internal audits.
- Support supplier approval and monitoring activities.
- Support complaint/incident and Non-conformity investigations and CAPA.
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:
- Life Science or Software Engineering degree
- Experience of working within an ISO 13485 environment.
- Experience of working in an IVD or Medical Device environment with a strong quality focus.
- Knowledge of Agile methodology.
- Excellent organisational skills for working on multiple projects.
- Commitment to on-going training.
- Experience of developing process and procedure writing.
- Ability to use problem solving tools and methodologies.
- Understanding of Clinical Decision Support Software.
- Working knowledge of ISO 13485, ISO 62304, ISO 14971.
- Experience of auditing.
For further information and to apply for this role, please click APPLY