Quality Assurance Medical Device
Resume:
David. A. Adeniyi
Mobile: 078*******
E-mail: *************@*****.***
PROFESSIONAL PROFILE
I am a results-driven and seasoned professional with over 18 years of extensive experience in the medical device and pharmaceutical industries, consistently demonstrating a strong record of success. I possess a diverse skill set and am committed to delivering high-quality results. I have a keen eye for detail and a passion for continuous learning and innovation
KEY COMPETENCIES
Technical
Investigation and CAPAs
Complaints Handling
Risk Management
Medical Device Operations
Quality Assurance
Interpersonal
Team player/Collaborative
Problem solving
Results/Target focused
EDUCATIONAL RECORD
Postgraduate Degree in Medical Device Technology and Business
Griffith College, Dublin, Ireland
Graduation Date: February 2025
Grade: Distinction
Certificate in Quality Assurance 7430 Parts 1&2
City & Guilds of London Institute, United Kingdom
Graduation Date: December 2004
Bachelor of Science in Biological sciences
Ahmadu Bello University, Zaria, Nigeria
Graduation Date: November 1999
ACHIEVEMENTS
As a Quality Assurance Representative, I successfully reduced the Fill Shop Order review by 25% using a risk-based approach (FMEA) and reduced Incoming Quality Assurance testing by 98% with the DMAIC-V technique
As a Quality Systems Engineer I developed and executed a training module for the bulk shop order review and buffer/diluent process, thereby streamlining the process and improving KPIs by 35%
As a Quality Systems Engineer, I successfully executed a 20% reduction in the testing of immunoassays using DMAIC-V Technique
During my time as a Product Development Engineer, I successfully designed and implemented a template for the design verification and validation summary report. This was identified as a key requirement during the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR)
CAREER HISTORY
Product Development Engineer (MDR Remediation Project)
Johnson & Johnson
Oberdorf, Baselland
Switzerland
August 2018 to July 2023
Identify and mitigate risks in the development process
Perform verification and validation (V&V) testing to ensure safety and efficacy
Leverage feasibility study insights to support regulatory submissions
Create and update RMP, RMR, CCD, F&DR, DFMEA and PFMEA
Review and approve drawing and labelling updates, including design impact assessments
Draft and submit comprehensive responses to deficiency reports from Notified Bodies
Draft, review, and approve procedures related to compliance activities, as well as other GMP/GDP and regulatory documentation.
Investigation and completion of deviations, root cause analysis, CAPAs, change controls and effectiveness checks
Production Risk Management Consultant
Johnson & Johnson
Hägendorf, Solothurn
Switzerland
January 2015 to November 2017
Author and review of technical file / DHF
Author quality documents, DCR/DCO (Design Change Request/Design
Change Order) and Training
Perform Benefit Risk Analysis and Post-Market Surveillance Plan
Write Production Risk Analysis documents in accordance with EN ISO 14971 (PFMEA)
Perform Investigation, root cause analysis, CAPAs, change controls and effectiveness checks
External audit and vendor qualification
Complaint Handling Manager / Global Remediation Quality Plan Consultant
Johnson & Johnson
Area Headquarters,
Zuchwil,
Switzerland.
September 2013 to December 2014
Evaluate event(s) to determine if it qualifies as a complaint
Review potential reportable events to determine if regulatory filings are required
Prepare complaint files for closure
Handle complaint investigations by coordinating with the intake service, overseeing decontamination, conducting analyses (laboratory, dimensional, physical-chemical) as needed
Quality Systems Engineer
Siemens Healthcare (Diagnostics)
Wales,
United Kingdom.
Mar 2013 to August 2013
Generation and independent review of validation lifecycle deliverables and documentation as required to ensure compliance with regulatory authorities and fitness for purpose of business systems and equipment
Provide QM support for Post market activitites and representation on various product related meetings (PHT, SSP/SPP/PQC, Immulite Quality meetings etc
Responsible for the effectiveness of CAPAs and internal/external audits
Quality Assurance Officer
Pharmacell Biopharma
Oxfordlaan, Maastricht.
Netherlands
Oct 2012 to Dec 2012
Review, check and approve batch documentation and any associated deviations to ensure they are satisfactorily completed prior to batch certification by the QP
Support in the completion of customer complaints, deviations, CAPAs and change controls, assisting in root cause analysis, prompt responses/ resolution and ongoing data evaluation to ensure any emerging trends are acted on
Manufacturing Quality Assurance Specialist/QA Representative
Abbott Diagnostics, Longford,
Ireland
September 2007 to October 2012
Author and implement procedure for the Diagnostic Reagent Operations
Testing of products using AxSYM and Architects techniques
Perform final product acceptance testing
Batch record review of GMP source documents and reports according to
Quality system procedures and legal regulations as applicable
Maintenance of CAPAs, deviations, reworks and change requests
Quality Control Analyst
Takeda Pharmaceutical, Bray, Co. Wicklow.
Ireland
Dec 2006 to Aug 2007
Finished product Testing i.e. Description, Disintegration, UV, Dissolution, HPLC
Karl Fischer titration, TLC, Loss on Drying
Calibration of analytical equipment
Draft, review and approve SOP
Manage change request system
Quality Control Inspector
Abbott Vascular, Clonmel, Co Tipperary.
Ireland
May 2005 to Sep 2006
Audit materials or the work of others through the examination, inspection, or test of raw materials, components, sub-assemblies, final assemblies and documentation
Document the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/components specification, SOP
Handle discrepant materials per the documented disposition and document activities in the appropriate systems or paperwork
HOBBIES & INTERESTS
Football
Staying up-to-date with the latest advancements in technology and industry trends
REFERENCES
Available upon request
Contact this candidate