Quality Engineer

Biocrucible is developing a class-leading molecular diagnostic platform based on its proprietary isothermal nucleic acid amplification technology. This platform has the potential to offer rapid results with PCR-like levels of sensitivity and specificity but in a fully-disposable format usable by both consumers at home and also in low-resource environments. Our technology can significantly improve the performance of many processes already currently in use throughout the life science and diagnostic industries. The acquisition by Sapphiros in July 2021 has provided further investment and operational support to accelerate this next-generation platform to market.

We require a Quality Engineer to maintain the company Quality Management System (QMS) procedures and processes and to help develop and communicate the Quality Management plan.

The specific roles and responsibilities are to:
• Prepare and implement the EQMS procedure documents (including SOPs and WIs)
• Support the R&D team in developing the Design History File and Design Trace matrix
• Work with contract manufacturers with respect to their Quality systems
• Support the manufacturing team in developing and executing the required validation activities (DQ/IQ/OQ/PQ)
• Perform internal audits
• Supplier Auditing/Monitoring
• Provide daily support to Production
• Risk Assessment and Management
• Create and Deliver Training Sessions – GDP, EQMS, GMP
• Continuous Quality Improvements
• Support the implementation of an EQMS
• Review and maintain the Non-conformances /CAPA process

Preferred Experience and Skills:
Experience of developing a quality management system
Understanding of quality and regulatory requirements for IVDs
Ability to influence and work as a team to deliver goals
Strong communication skills

Preferred Qualifications / Education:
BSc in relevant discipline preferred

Application Instructions: 

Please send a CV and covering letter to careers@biocrucible.co.uk should you wish to apply / you would like more information.

Application Closing Date: 
31 August 2022