BBI Solutions is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic market. Our portfolio includes the Novarum reader; a powerful software tool that lets you read and share the results of diagnostic assays (including lateral flow tests) using nothing more than a smartphone.
As a business, we are currently embarking on a period of substantial growth and investment, which has led to the requirement to recruit additional talent to the business. This includes the opportunity to recruit a Quality Engineer into our growing Novarum team.
As the Quality Engineer, you will lead on Quality Assurance activities of the business processes. You will work with the team to ensure compliance of design and development activities as well as all other business areas addressed by the QMS.
Key duties and responsibilities will include but not be limited to the following:
- Schedule and conduct internal audits, and supplier evaluation
- Liaise and support external and regulatory audits
- Ensure that processes needed for the Quality Management System (QMS) are established and maintained
- Work with team to ensure compliance
- Report on the performance of the QMS; participate in quality management reviews
- Investigate Complaints arising from customer Service desk
- Participate in project reviews to ensure appropriate design controls are being met
- Promote awareness of quality and regulatory requirements
- Support validation activities
As the Quality Engineer, you will be somebody who is able to work unsupervised and communicate effectively with your team, pears and customers.
You will be somebody who is competent with software tools for reporting, and the use of cloud based systems and you will ideally hold the following Qualifications and experience:
- Internal Auditor Training to ISO 13485
- Significant Experience in a similar role
- Experience of working with medical devices / IVD through the development lifecycle
- Experience of complaints handling and CAPA process
- Experience in Process Validation.
- Physical Sciences to Degree Level
It will be key that you can apply your compliance knowledge to software, it’s development and lifecycle.
BBI is a fast-paced and agile business, with a track record of growth, and the opportunity to influence and direct the business going forward. We deliver exceptional products and technologies that people rely on to enjoy a better quality of life. We look for our people to be active participants in BBI life, to make work fun as well as challenging.
To apply click here…