Thank you for taking an interest in the career opportunities at ERBA Molecular; we are a successful and dynamic company that is always looking to add the right candidate to our team.
ERBA Molecular is a molecular IVD company with a novel, commercially validated and integrated diagnostic system. ERBA Molecular’s approach to simplified workflow employs proprietary sample preparation innovations that integrate with ERBA Molecular’s next generation isothermal amplification technologies as well as existing amplification methods. Together with ERBA Molecular’s unique real-time detection system this combination provides a low cost, easy to use molecular solution for near-patient or decentralised testing.
If you have a BSc or higher and wish to have an opportunity to learn about cutting edge molecular diagnostic technologies we would like to hear from you. Working at ERBA Molecular you will have the opportunity to learn how the scientific team integrates the disciplines of bioinformatics, wet chemistry, assay design and optimisation. The team at ERBA Molecular combine those skills to develop easy to use robust assays within our highly efficient development cycle time.
Purpose of Job
On a day-to-day basis the QA Specialist will support business and operational quality management and planning activities at a local level in Ely in preparation for the site's first ISO13485 certification audit during 2019.
Working intimately with Erba Molecular IVD scientific, engineering and operations teams, key requirements of this very hands-on role are:-
- Maintain the local QMS to ISO13485:2016
- Work with corporate compliance team to integrate QMS into corporate QMS, release corporate SOP's and train teams on those
- Act as the QMS document controller, manage local change control
- Help create, monitor and improve R&D process documentation and version control
- Provide Quality support to cross-disciplinary IVD project level planning
- Provide IVD QA\RA inputs into product Design History File and Technical File creation
- Carry out internal and external supplier audits as per corporate procedures, non-conformance and CAPA activities
- Carry out self-directed research into applicable QA and RA compliance standards for a range of IVD products
- 5+ years experience in ISO 13485 Quality Management Systems within a MD\VD product development environment
- 5+ years industry experience in QA
- IVDD\IVDR clearance planning, Quality Planning, Validation Planning, Maintenance of Design History Files, Manufacturing Transfer Planning, Clinical Trial Planning, Risk Management and FMEA
- BSc in life science discipline
- Experience working with competent authorities and notified bodies
- Experience with internal audits
- Experience working with scientists and\or electronic engineering and software engineering disciplines
- Self-directed and able to manage multiple strands of QA activity simultaneously
- Able to apply a sense of urgency, commitment and focus on the right priorities in driving QMS development and compliance
- Pragmatic approach to Quality Management and able to mentor and quickly gain 'buy-in' from teams with limited QMS experience
- Confident trainer in different formats (e.g. 1:1, classroom, presentations and coaching)
- Excellent organisation skills
- Good technical writing
- Excellent verbal and written communication skills, particularly when working with cross-functional teams