- Edinburgh, UK
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ™, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities.
MosaiQ™ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Switzerland, Scotland and USA.
Quotient are recruiting a Quality Assurance Engineer to join the team based in Edinburgh (EH26 0BF) where we develop and manufacture our high quality, high value, in vitro diagnostic, immunohaematology (blood banking) Alba by Quotient products sold to hospitals and blood banks around the world. Development and manufacturing capabilities include pilot and large-scale mammalian cell culture, polyclonal antibody formulation, liquid fill, and packaging. The Edinburgh facility operates to current Good Manufacturing Practice and our Quality Management System (QMS) aligns with requirements of 21 CFR 600 and 820 as well as ISO 13485: 2016.
This role entails maintaining collaborative relationships with colleagues from all areas in the business to ensure on-going quality improvement while maintaining compliance to internal procedures and international standards. The successful applicant will be responsible for the following:
- Compliance management for allocated process area, including but not limited to
- Internal investigations/root cause analysis
- Change proposal and implementation
- Support internal and external audit process
- Process performance review
- Trend key business and quality critical parameters
- Identify and define proactive actions to respond to trends
- Process improvement
- Science background is required, with appropriate experience in a Quality Assurance role, preferably within Medical Device or GMP industries
- Continuous improvement of existing processes and activities to maximise resources
- Competitive Salary on offer
- Quotient offer a competitive salary as well as a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.
- Closing date: open until filled.