Quality Assurance Management
Resume:
Kay Ogunsolu
Grand Prairie, TX 75052
Cell Phone #: 773-***-****
************@*******.***
Expertise: Quality Management,Supplier Development & Management, Kaizen and Continuous
Improvement, Manufacturing Operations, FDA Device Control, Process Validation,Engineering
Operations & Management, Product Development Engineering, Medical Device Engineering, Project &
Process Management.
Certifications: ASQ Certifications; Quality Process Analyst, Quality Auditor. Six Sigma Black Belts, ISO
13485 & 9001 QMS Lead Auditor.
Education
University of Illinois at Chicago, IL
Masters, Electromagnetic & Engineering Management Jan.19th 2004 – Dec 12th.2005
University of Lagos.
Bachelors, Electrical Engineering Sept.1995
Zimmer Surgical May 2013- till date
QA/RA Manager
Provide overall leadership and direction to the site Quality Operations department and direct the
development and implementation of the site Quality Systems and programs to ensure compliance with
company policies and procedures and industry regulations and standard, including FDA cGMPs,
CFRs, ISO 13485:2003, MDD and CMDR.
Responsible for the collection, analysis and reporting of key performance indicators relative to the
Quality function.
Review and monitor internal technical problems and quality issues, field complaints, field service and
supplier quality issues and implement solutions to problems or change in procedures.
Manage the activities for Quality Assurance, Validation and Quality Control functions to maximize
efficiency of staff, equipment and financial resources to support company goals while ensuring
compliance to company policies and applicable regulatory requirements.
Support internal audit program and ensure timely implementation of corrective/preventive action.
Monitor the quality of products and implement systems and strategies to ensure products continue to
conform to established specifications and Zimmer expectations.
Lead the business during any regulatory agency inspection, field complaint inquiries and other
interactions and ensure timely responses to any requests or issues which may be identified.
Manage all phases of cost reduction projects including justification, requirement definition,
implementation and design transfer.
Provide technical expertise and knowledge in Risk Management activities in all stages of product
Ensures that all procedures and records are in compliance with company, FDA and ISO requirements.
Lead Corrective and Preventive Action (CAPA) projects.
Initiates, develops and implements industry best practices designed to increase product value and
quality and team effectiveness.
Design, plan and execute protocols to evaluate concept feasibility
Investigate escalations of technical support and complaints of product issues to determine a mitigation
or resolution providing technical training as needed.
Flextronics Medical Nov.5, 2007- May 2013.
Supplier & Quality Operations Manager
Function as Management Representative responsible for reporting Global KPI for the Design and
Manufacturing site and Quarterly Business Report (QBR).
Managed the effectiveness of the QMS through quality objective, metrics and goals that have been
established at relevant functions and levels within the organization.
Directly responsible for ensuring timely and effective supplier development process for new and
sustaining production components and sub-systems in support of cost savings strategies.
Provided support to Engineering, Manufacturing, Supply Chain & R & D with process or quality
issues, driving quick resolution to ensure a successful launch of new products and sustaining
manufacturing operations.
Maintained US FDA, GMP compliance companywide.
Maintained project DHFs in accordance with FDA Design Controls Guidelines and ensured successful
product transfer to manufacturing.
Managed the activities of the QA/QC department and oversea daily production activities.
Development and deployment of plant level quality systems procedures
Managed Internal Audits and support all third party audits including Customer and Regulatory Audits.
Managed the facility environmental control program for the clean rooms and release reports.
Managed the site supplier program inclusive of standards for raw material risk assessments and
specification management.
Provided technical guidance to quality engineers, quality technicians and inspectors and support
operations activities for FAIR (First Article Inspection Report) for new component and suppliers.
Managed supplier selection, supplier development, supplier scouting & match and supplier
improvement activities audit planning, audit report. Report and ensure timely closure of SCAR.
Participated in Design Review of new products.
Developed consistent supplier interfaces in the areas of selection, audit, change management, supplier
agreements and works with supplier chain teams to identify potential efficiency improvements and
cost reduction opportunities.
Advocated product standardization, utilization, purchasing and supply chain best practices by utilizing
and leveraging distribution, logistical, and operational capabilities.
Drive continuous improvement and lean initiatives by ensuring effective cost savings during product
realization and manufacturing. Over $760k cost saving initiatives and projects-supplier in 3 yrs.
Managed and mentored quality engineers and associates on Design control and compliance to
company’s company corporate requirements. Assisted program management with resource allocation,
ensuring the proper design and project engineering resources are assigned to programs.
Performed compliance risk assessment to determine the need for and the prioritization of compliance
corrective action.
Managed product and process risk assessment activities, including hazards analysis, and
design/process failure modes and effects analysis (DFMEA/PFMEA).
Provided regulatory guidance and support Design and Process Validation activities for new products.
Reviewed sterilization and other validation data and final validation reports to ensure completeness
and accuracy.
Managed Material Review Board (MRB) and coordinate CA/PA metrics.
Reviewed DMR document, and validate inspection and test methods to support design control, in-
process inspection, and final inspection activities.
Supported corrective and preventive action process for product/process non-conformances, customer
complaints, and internal audits.
Chairman,Validation Steering Committee; directed the validation activities to support manufacturing
equipment validation, facilities and utilities and ensure that all items cleaning and sterilization
processes are validated in accordance with appropriate regulatory requirements, cGMPs, corporate
policies and procedures.
Tracked quality trends and initiate action items to resolve issues, manage corrective actions and
complaint investigation.
Participated in customer/strategic partner visits.
Ethicon Endo Surgical Inc.
Principal Quality Engineer/SQE Feb. 2005-Sept.2007
Authored validation, verification, and inspection assessments to ensure the defensibility of product
test data.
Responsible for Supplier Corrective Action Request (SCAR), CA/PA, customer complaints, and
internal audits.
Provided hands on expertise and support in resolving and mitigating product requirements and
compliance.
Developed measurement systems to monitor effectiveness of QA and Reliability systems to identify,
bracket, correct and prevent defects to demonstrate continuous improvement to management.
Prepared QA systems and assist in technical issues for manufacturing process that are to be transferred to satellite facilities.
Reviewed and approved functional & specification requirement check sheet, unit data, material and travelers sheet, burn-In report, external manufacturing certificate of compliance & electronic assembly, label reconciliation and confirmation sheet and ensure compliance to EES quality systems and software validation activities.
Ensured compliance and audit readiness of new and sustaining suppliers.
Managed the performance of quality assurance functions including product release, document
creation and control, assuring that products and processes meet company and regulatory
requirements.
As a Test Engineer, conducted software validation, program logic boards, semiconductors, PCBs,
board test, LCDs, Control module, Burn-In and other reliability testing.
Wrigley Manufacturing LLC (Nov. 2003- March 2004)
Quality Assurance Supervisor.
Provided work as many of the following: SOP / OSHA / GMP / FDA / facility maintenance.
Developed HACCP audits, and ensured GMP compliance companywide.
Designed a Capacity Module; a production module designed to monitor daily plant optimization,improve efficiency, yields and quality.
Utilized SPC and other quality tool to drive daily production yield and line optimization.
Investigated customer complaints and providing Corrective Action Reports for both internal
improvements and customer satisfaction.
Coordinated investigation and disposition of all customer complaints and presented this information on a monthly basis to the Management Team.
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