Deanne joined our Quality Assurance team in January 2020, and helps to provide an internal service provision to everyone at Team for all things ‘QA’. She is responsible for ensuring we meet the requirements of regulations and our clients’ commercial goals. She also supports the development of a quality management system compliant to CFR 820 and ISO 13485:2016 that balances our systems and processes with those of our clients.
“Effective quality assurance is an important part of our work, and it’s Team’s friendly working culture and collaboration that allows us the opportunity to make real improvements to the way we approach it. I am excited about working to uphold compliance within our processes at such a thriving, exciting medical device consultancy business.”
Deanne has enjoyed a 25-year career in production operations, quality assurance and quality engineering for manufacturing pharmaceutical companies and R&D medical device development. She has significant QA experience, having worked in a next generation sequencing software start-up company where she set up the quality management system from scratch, and was a key participant in the successful achievement of BSI Notified Body Certification for ISO 13485.
Most recently, Deanne spent 7 years in design control compliance for different drug-device combination products, supporting a successful US (FDA) and EU (EMA) approval for a prefilled pen drug product program. She holds a post graduate certificate in Management Studies from Anglia Ruskin University, and is a qualified IRCA Lead Auditor, with professional status PCQI as Practitioner of the Chartered Institute of Quality.