Abiola Bamigbade

Head of Quality and Regulatory Affairs @Kays Medical Ltd

Luton, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2020 — Present

Head of Quality and Regulatory Affairs @Kays Medical Ltd

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Liverpool, GB

As the Head of QARA, responsible for the implementation of the group QMS and corporate strategy. The management representative responsible for the effective implementation of regulatory, compliance, quality assurance and quality system requirements for all relevant medical devices manufactured by the business. The primary point of contact for the business with respect to Registrars, Notified Body and National Health Competent Authorities and essentially maintains the Technical Files, Design Dossiers and Device Master Records. Primarily responsible for product registration and certification for the business product portfolio as well as the management of Suppliers and EU Representative.

EDUCATION

2004 — 2005

University of Hertfordshire

Master of Science (MSc), Manufacturing Systems Engineering

2020 — 2025

University of Buckingham

Professional Doctorate in Operational Excellence

SKILLS

PowerpointMicrosoft ExcelQms AdministratorAnalysisSupervisory SkillsResearchCustomer ServiceContinuous ImprovementInternal AuditManagementWindowsEnglishEdms Super-UserTeachingQuality AssuranceMicrosoft OfficeEngineeringMicrosoft WordOutlook

ABOUT ABIOLA BAMIGBADE

I am really keen about achieving incremental changes through continuous improvement techniques of processes and projects.Previous experience includes: Training coordinator, developed and reviewed training materials to update volunteers\' skills. Document control and management including the review of production batch records for deposition teams to effect the production of a generic document for multi-process use within the department. Process improvement projects coordination using root-cause analysis to investigate high production time downtime as a result of incessant machine stoppages.

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Abiola Bamigbade — Head of Quality and Regulatory Affairs at Kays Medical Ltd in Luton, GB | Unifers