Quality Assurance Engineer
- Edinburgh, UK
Quotient is a well-established bio-manufacturing organisation where we develop and manufacture high quality, high value, in vitro diagnostic, immunohaematology (blood banking) products which are sold to hospitals and blood banks around the world. We offer contract services to the bioscience industry and currently manufacture products for major global players in the Life Sciences sectors. Development and manufacturing capabilities include pilot and large-scale mammalian cell culture, polyclonal antibody formulation, liquid fill, and packaging. The company is poised for significant growth in this specialized field of medicine through the development and commercialisation of the next generation automated platform for transfusion diagnostics, MosaiQ™. Quotient manufactures according to current Good Manufacturing Practice. With our facilities growing in Edinburgh, Switzerland and the US, now is an exciting time to join the company as we advance our product portfolio!
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.
The role is a full time, permanent position with flexible working hours.
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 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