Folorunso Obadeyi
Macquarie Park,New South Wales
Summary
Dynamic, results-focused Electrical and Electronics Engineer with expertise in Quality Management and Organizational Excellence. Skilled in driving continuous improvement initiatives, optimizing processes, and enhancing performance in the medical device industry. Proven ability to prioritize, tackle challenges, develop innovative programs, and analyze complex situations to increase efficiency. Strong negotiator and relationship builder with suppliers and business partners. Quality control professional experienced in developing organization's quality strategy, procedures and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO 13485, ISO 9001 and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager(Supplier/Commercial Q)
SMA Solar Technology AG
01.2024 - Current
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Enhanced product quality by implementing comprehensive QA processes and procedures.
- Lead quality activities in providing complete problem resolution of product failures
- Initiate, manage and track the verification process of product problems or failures, initiating, participating and driving corrective actions, utilizing the 8d step process
- Coordinate remedial actions with Supplier Quality Engineers, Production Quality, Engineering, Field Service personnel as required in resolving product quality issues
- Participation as a leader/team member of Lean, continuous improvement, 5W’s, Pareto, Ishikawa and Kaizen initiatives and projects on multi-disciplinary teams for corrective and preventive action
- Interface with international colleagues in the continuous improvement of product quality
- Conducted regular audits to ensure adherence to established protocols, maintaining consistency across the organization.
Product Quality Manager
Device Technologies
10.2021 - 12.2023
- Fostered cross-departmental collaboration with RAQA Management and Business Management, effectively resolving concerns related to Device Group Post-Market Vigilance and Product Quality
- Enhanced compliance by expertly reviewing and advising on external regulatory reports and requirements of Post-Market Vigilance activities
- Drove the alignment of quality resources with business growth strategies, facilitating the introduction of new products, processes, and facilities
- Coached and developed team members, enhancing their competencies and performance
- Strengthened partnerships by cultivating and maintaining excellent working relationships with key regulatory bodies and government departments
- Guaranteed alignment with industry standards by continuously reviewing and updating work instructions and guidance documents for RAQA Post-Market activities and processes
- Spearheaded and facilitated improvement projects for the RAQA Post-Market Team and other departments, driving innovation and process optimization.
- Reduced Product Complaints resolution time by over 50%
Lead, Commercial Quality
Bayer Pharmaceuticals (Radiology Division)
09.2020 - 10.2021
- Streamlined product quality by proactively identifying and eliminating potential nonconformances in products, processes, and quality systems, resulting in enhanced compliance and efficient escalation management
- Cultivated departmental leadership talent, preparing the team for scalable growth
- Represented Regulatory Compliance at selected cross-functional meetings communicating lessons learned from failure analysis of complaint to design teams and manufacturing teams
- Expertly executed Recalls/Field Corrective Actions and other product quality-related activities, minimizing business disruption and safeguarding brand reputation
- Enhanced customer satisfaction by serving as the primary contact for customer experience reporting and complaint handling, swiftly resolving issues related to Contrast Injectors and Sterile Consumables
- Boosted product performance and customer satisfaction by comprehensively analyzing product complaints, identifying trends, and implementing corrective and preventive actions
- Leveraged expertise in electronic data capture systems and analytical tools to optimize data visualization and insights, driving informed decision-making and process improvements
- Delivered data-driven insights by preparing and presenting quarterly KPIs, empowering leadership to make informed decisions and drive continuous improvement
- Promoted compliance and audit readiness by representing Complaint and Post-Market Vigilance in regulatory interactions, presenting processes, and supporting inspections
- Fostered a safe and healthy work environment by promoting and maintaining occupational health and safety standards in compliance with Bayer ANZ Occupational Health and Safety Policy
- Enhanced patient experience by leading specialist functions, analyzing complaint trends, and collaborating with crucial performance units to develop and implement effective complaint prevention strategies.
Supplier & Commercial Quality Engineer
Bayer Pharmaceuticals (Radiology Division)
10.2019 - 09.2020
- Comprehensively monitored quality across the entire Quality Management System (QMS) and product lifecycle, encompassing design, operations, supplier controls, acceptance activities, and post-distribution surveillance
- Prepared and submitted authority notifications for medical device incidents and field safety corrective actions, ensuring timely reporting and compliance
- Evaluated supplier performance and reported findings to management, driving continuous improvement in supplier quality
- Collaborated in developing and implementing supplier management programs to optimize vendor relationships and performance
- Served as the primary supplier quality representative for root cause and corrective action analysis, resolving supplier-caused manufacturing issues
- Managed and oversaw metric reporting processes, demonstrating the quality system's effectiveness and identifying improvement areas
- Efficiently facilitated the nonconforming product resolution (NCR) process, ensuring timely and effective resolution of quality issues
- Established and maintained robust processes and procedures to meet quality targets for processing and investigating complaints, management notification, system surveillance and trending
- Supported quarterly site management review board meetings, preparing and presenting data related to material and supplier controls and customer complaints
- Project-managed Continuous Improvement projects with the outputs leading to zero audit findings
- Diligently reported adverse events to TGA/Medsafe and other regulatory bodies, maintaining transparency and compliance in adverse event management.
Quality Engineer
Cogstate
03.2019 - 12.2019
- Ensured software validation approach and associated documentation adhere to applicable medical device software regulations, ISO 62304, Software as a Medical Device and other applicable regulatory requirements
- Responsible for QA verification for new platform and product development and version releases
- Prepared Validation Plans and reports as required
- Maintained a Quality Management System that ensured that Cogstate is compliant with appropriate regulatory guidelines including ICH Good Clinical Practice E6, Electronic records handling as defined by FDA regulation 21 CFR Part 11, Medical Devices Regulations, and other applicable regulations
- Reviewed and approved software configurations for study preparation
- Coordinated review and approval of outsourced processes; Assist in Vendor Management activities such as Vendor audits, vendor file management and updates
- Authored and completed ongoing review of QMS documentation, highlighting any gaps encountered with reference to FDA QSRs, ISO 9001, ISO 13485, 21 CFR Part 11 and other applicable regulatory requirements.
Operations Quality Associate
Leica Biosystems
10.2016 - 10.2019
- Troubleshot and resolved instrument faults, improving overall system reliability
- Identified test tools, defined requirements, and verified test tool performance, enhancing testing efficiency
- Streamlined Process Control Procedures (PCPs) by actively participating in their development and review
- Validated robotic designs and control systems, ensuring optimal performance and reliability
- Reduced nonconformity by managing NCR-Reports, monitoring, investigating, and implementing practical solutions
- Verified fluidic designs and control systems, enhancing efficiency and performance
- Validated mechanical, electrical, and electronic designs, ensuring compliance and operational excellence
- Efficiently resolved manufacturing quality issues through cross-functional collaboration and timely problem-solving
- Boosted product experience handling awareness by implementing and managing internal training processes
- Maintained and adhered to up-to-date and compliant quality operational processes, in accordance with ISO 13485 and 21 CFR Part 820 regulations and adapted to the changing requirements of the business.
Quality Assurance Operative
Simpson Group
09.2015 - 08.2016
- Maintained consistent quality throughout the production process, enhancing product performance
- Collaborated in reviewing and updating work instructions and procedures, ensuring continuous process improvement
- Guaranteed completion and sign-off of all relevant quality records, reinforcing compliance and traceability.
Manufacturing Quality Engineer
Impasse Technologies Ltd
03.2012 - 06.2015
- Optimized manufacturing efficiency by skillfully troubleshooting and maintaining critical equipment
- Established equipment specifications and refined manufacturing techniques, enhancing overall productivity
- Inspected machinery, equipment, and tools to verify optimal performance, proactively addressing problems and deficiencies to maintain product quality
- Designed and executed systems improvement projects, collaborating with maintenance and production groups to resolve technical and engineering issues
- Implemented corrective and preventive actions (CAPA) to address identified issues and prevent recurrence
- Reviewed capital equipment fabrication activities to ensure compliance with functional specifications, regulatory safety standards, and user requirements
- Developed cost estimates, secured quotes, and generated capital requests to support introducing new processes and acquiring capital equipment.
Education
Master of Science in Medicine (Pharmaceutical and Medical Device Development) -
University of Sydney
Sydney, AustraliaBEng: Electrical and Electronics Engineering -
University of Sunderland
Sunderland, United KingdomHND: Electrical and Electronics Engineering -
Moshood Abiola Polytechnic
Skills
- ISO 9001
- Quality Management
- Continuous Improvement
- Regulatory Compliance
- Performance Metrics
- FDA 21 CFR Part 820
- Quality Assurance and Control
- Project Engineering
- Project Management
- GMP
- GDP
- QMS Implementation
- Medical Device QMS Auditing
- ISO 13485:2016
- ISO 14971
- CAPA & Root Cause Analysis
- ISO 14001
- Medical Device CE Certification
- MDSAP Audit
- Decision-making capabilities
Certification
- ISO 13485:2016 Certified Lead Auditor
- ASQ CQM/OE - Certified Quality Manager/Organizational Excellence
- BSI Certified (ISO14971:2019 Risk Management for Medical Devices
- BSI Certified Requirements of the Medical Device Regulation (MDR)
- BSI Certified (ISO 13485:2016 Clause by Clause)
Timeline
Quality Assurance Manager(Supplier/Commercial Q)
SMA Solar Technology AG
01.2024 - Current
Product Quality Manager
Device Technologies
10.2021 - 12.2023
Lead, Commercial Quality
Bayer Pharmaceuticals (Radiology Division)
09.2020 - 10.2021
Supplier & Commercial Quality Engineer
Bayer Pharmaceuticals (Radiology Division)
10.2019 - 09.2020
Quality Engineer
Cogstate
03.2019 - 12.2019
Operations Quality Associate
Leica Biosystems
10.2016 - 10.2019
Quality Assurance Operative
Simpson Group
09.2015 - 08.2016
Manufacturing Quality Engineer
Impasse Technologies Ltd
03.2012 - 06.2015
Master of Science in Medicine (Pharmaceutical and Medical Device Development) -
University of Sydney
BEng: Electrical and Electronics Engineering -
University of Sunderland
HND: Electrical and Electronics Engineering -
Moshood Abiola Polytechnic
- ISO 13485:2016 Certified Lead Auditor
- ASQ CQM/OE - Certified Quality Manager/Organizational Excellence
- BSI Certified (ISO14971:2019 Risk Management for Medical Devices
- BSI Certified Requirements of the Medical Device Regulation (MDR)
- BSI Certified (ISO 13485:2016 Clause by Clause)
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