Jenni Quaye

Partner with project, account management, and quality stakeholders to implement and improve client-specific quality, training, and operational processes. Lead quality assurance activities, analyze call-monitoring and case-review findings, and coordinate training and competency assessments.

Supported the Legal Manufacturer site QMS in accordance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and EU IVDR. Led SharePoint-to-SAP document migration projects across multiple sites and acted as LMS subject matter expert.

Worked with department heads and line managers to establish learning and development matrices across business units. Supported LMS optimisation, administration, and process improvement, and compiled compliance reports.

Helped develop and implement a fit-for-purpose QMS aligned with ISO 13485, FDA 21 CFR Part 820, EU MDR, and EU IVDR. Reviewed and approved verification and validation documentation, managed change control activities, and designed a standardised LMS.

Led the rollout of Teamcenter Unified at the Elstree site, acted as subject matter expert, and developed document control processes. Managed document management improvement initiatives and line-managed Quality Systems Documentation Controllers and Training Coordinator.

Maintained SOP gap analyses and identified GxP training requirements with line managers and HR. Coordinated induction, GxP, and periodic retraining across UK and European teams, and audited personnel training records.

Conducted and supported UK and European audits against ISO 13485, managed audit findings, CAPAs, deviations, change controls, and complaints. Facilitated implementation and ongoing improvement of Oracle Agile eQMS and Oracle Learning Module.

Supported establishment and maintenance of the QMS in line with ISO 13485, FDA 21 CFR Part 820, and applicable EU medical device and IVD requirements. Managed LMS activities to assign and track employee learning.

BSc (Hons) Biochemistry degree from the University of East London, completed in 1997.