David Adeniyi
Olten,SO
Summary
Result driven professional with 18+ years of experience in the medical device and pharmaceutical industries, specializing in product development, quality assurance, regulatory compliance, and cross-functional collaboration. Known for delivering high-quality results, meticulous attention to detail, and a commitment to innovation. Aiming to leverage expertise to drive impactful advancements in healthcare.
Overview
18
18
years of professional experience
Work History
Product Development Engineer (MDR Remediation Project)
Johnson & Johnson
Oberdorf
08.2018 - 06.2023
- 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 labeling 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
01.2015 - 11.2017
- Author and review of technical file / DHF
- Implement DCR/DCO (Design Change Request/Design Change Order)
- SOPs update and training
- 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
Zuchwil
09.2013 - 12.2014
- 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
03.2013 - 08.2013
- 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 activities 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
Maastricht
10.2012 - 12.2012
- 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
09.2007 - 10.2012
- Author and implement a procedure for the Diagnostic Reagent Operations.
- Testing of products using AxSYM and Architects techniques.
- Perform final product acceptance testing.
- Shop order 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
12.2006 - 08.2007
- Conduct comprehensive testing for pharmaceutical product quality using UV, HPLC, Karl Fischer titration, and TLC.
- Calibration of analytical equipment.
- Draft, review, and approve the SOP.
- Manage the change request system
Quality Control Inspector
Abbott Vascular
Clonmel
05.2005 - 09.2006
- Audit materials or the work of others through the examination, inspection, or testing 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
Education
Postgraduate Degree - Medical Device Technology and Business
Griffith College
Dublin, Ireland05-2025
Certificate - Quality Assurance 7430 Parts 1&2
City & Guilds of London Institute
United Kingdom01-2005
Skills
- Investigation and CAPAs
- Medical Device Operations
- Verification and validation
- Design Control
- Audits
- Batch Record Review
- Supply Chain
- Training
Contact
- Mobile, +41782600706
- Email, davida_deniyi@yahoo.com
References
Available upon request
Key Competencies
Risk Management, Complaints Handling, Operational Excellence, Quality Assurance, Team player/Collaborative, Problem solving, Results/Target focused
Personal Information
Hobbies: Football, Staying up-to-date with the latest advancements in technology and industry trends
Timeline
Product Development Engineer (MDR Remediation Project)
Johnson & Johnson
08.2018 - 06.2023
Production Risk Management Consultant
Johnson & Johnson
01.2015 - 11.2017
Complaint Handling Manager / Global Remediation Quality Plan Consultant
Johnson & Johnson
09.2013 - 12.2014
Quality Systems Engineer
Siemens Healthcare (Diagnostics)
03.2013 - 08.2013
Quality Assurance Officer
Pharmacell Biopharma
10.2012 - 12.2012
Manufacturing Quality Assurance Specialist/QA Representative
Abbott Diagnostics
09.2007 - 10.2012
Quality Control Analyst
Takeda Pharmaceutical
12.2006 - 08.2007
Quality Control Inspector
Abbott Vascular
05.2005 - 09.2006
Postgraduate Degree - Medical Device Technology and Business
Griffith College
Certificate - Quality Assurance 7430 Parts 1&2
City & Guilds of London Institute
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