Senior Quality Engineer - Complaints
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
Senior Quality Engineer - Complaints - based at our site in Bathgate, some remote working may be possible
We are recruiting for a Senior Quality Engineer to work within our Complaints team at our site in Bathgate. Reporting to the LumiraDx Quality Lead, the successful candidate shall be accountable for maintaining compliance of the LumiraDx Stirling Quality Management System, management of complaints and post-market activities ensuring that the requirements of ISO 13485:2016, CFR 21 Part 820 IVDD/IVDR are implemented in full. The successful candidate will be a subject matter expert able to lead post market activities and manage other quality personnel (as required) to achieve required business goals and drive quality improvements. The role will require significant interactions with LumiraDx key stakeholders and on occasion with external parties (e.g., suppliers, external auditors). Activities such as document/process creation, review and approval of documents, vigilance reporting, report writing, and development of trend analysis are requirements of this role.
- Coordination of QMS activities associated with post market vigilance and complaints to meet the wider business goals.
- Prepare and create documents and records for upload on to the document management system
- Review and approve complaint investigations ensuring adherence with relevant standards, regulations and QMS processes
- Monitoring of team KPIs, delivering on local and global team goals and objectives.
- Continual development of QMS processes driving lean practices throughout the team
- Coach and support in the writing of procedures, instructions and risk assessments
- Maintaining compliance of the QMS
- Ensuring timely completion of post market and vigilance related activities
- Support and input to internal / external audits
We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in communication along with the following experience:
- Technical background with minimum Bachelor’s degree in a Science or Engineering discipline, or other qualification with relevant industry experience
- Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820
- Extensive experience of working on post-launch IVD or medical device activities in a quality role
For further information and to apply for this role, please click APPLY