Here at The BBI Group, we are seeking individuals to support our work as part the UK-Rapid Test Consortium, tasked with developing and manufacturing a Covid-19 Point of Care antibody test
This test would be used by people in their homes to determine if they have an antibody response to COVID-19, which would confirm previous infection. The test, together with the Government’s overall strategy on testing and vaccination, support a move towards detecting and eradicating the virus.
This is a unique opportunity for you to join a progressive and growing organisation, which is contributing to the UK’s resistance to the pandemic.
Join us on our mission, we are currently hiring a Quality Engineer on a fixed-term basis at our Global Headquarters in Crumlin, South Wales. Flexibility is required to accommodate the rotating shift patterns across days and nights for this role.
BBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market. Product ranges include antigens, antibodies, enzymes, serums and plasma’s as well as renowned labels for lateral flow and ELISA assays.
Our mission is to deliver exceptional products and technologies that people rely on to enjoy a better quality of life. Through innovation, partnership, effective delivery and the collaboration of our people, we constantly strive to help set industry standards, engender trust and build our reputation for excellence.
Recognising that our people are our strength, we offer an attractive benefits package to our employees:
5% Contributory Pension Scheme
Life Assurance (4x Annual Salary)
Private Health Care Scheme
Global Employee Wellbeing Programme
Generous Annual Leave Package
Cycle to Work Scheme
Refer A Friend Scheme
Free Onsite Parking
As a Quality Engineer, you will be responsible for supporting the team with four main objectives. These include audits, system improvements, documentation review and approval and assuring consistent production quality.
Key responsibilities will include but not be limited to;
Review of internal records to ensure they have been completed to the required standard
To identify and record any non-conformances to requirements
Process development and improvement
Review of process documentation
Product inspection and internal audits
Support with problem solving – non-conformance review
Attend relevant production meetings
Work with the with Quality Operations Leader to develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release.
Participate in change control process to review and approve change requests.
Work with Manufacturing to coordinate and prioritise production processes to ensure compliance to ISO 13485, 21CFR820 and applicable regulatory requirements
Provide support to all teams across the Crumlin site by applying quality tools including, but not limited to: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC, as appropriate
Support in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis, & document health risk assessment.
Support Quality Engineers with Product recalls in line with management as appropriate.
Ensure support is provided for the maintenance of relevant technical files.
To be successful in your application you will need a Science degree and/or relevant industry experience. Knowledge of Lean Techniques, ISO 13485 and auditor experience would also be advantageous.
We are seeking an individual who is motivated by the need for continuous improvement and enjoys problem solving. Communication and organisation are key demonstratable behaviours, in addition to a customer focused approach for both our internal and external stakeholders.
If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.
Quality Engineer (Fixed Term)