Quality Assurance Medical Device
Resume:
Curriculum Vitae
Nkeiru Green
Sr. Compliance and Quality Consultant
SUMMARY OF QUALIFICATIONS
• Professional with a diversified background and 11 years experience in Compliance and Quality Assurance.
• Proficient in compliance, auditing, investigations, Corrective and Preventive Action (CAPA), product
complaint, adverse event evaluation, SOP development and assessment. Industry experience specialty in
Quality Assurance, Quality Control, Regulatory Affairs, Utilities/Facility, FDA Regulations (CFR 210/211,
820), ISO 9001/2008 and ISO 13485, CMDCAS,CAPA, Regulatory and Quality, within the Pharmaceutical,
Biologics and Medical Device industries.
PROFESSIONAL EXPERIENCE
2012-2013 Client: DepuySynthes, West Chester, PA
Consultant
• As the Sr. Compliance and Quality Consultant, I was the MDR project manager and my role was to manage the
retrospective MDR activity.
• Managed the MDR (Medical Device reporting) remediation efforts at the customer’s site with a team of 9 consultants.
• Wrote the protocol for the project and trained MDR team members on procedure and project details.
• Assisted the PMRM (Post market risk manager) in the forward movement of the remediation project in order to meet
deadline.
• Ran daily reports of progress and helped team make MDR reportable decisions.
• Identified Issues and corresponded with customer on ideas to resolve the issues quickly and within regulations.
• Ensuring that all functions of Quality Assurance are consistently in compliance with regulatory requirements
and corporate standards.
• Assessing risk to both end users and patient.
2011-2012 Client: Lonza Biologics, Hopkinton MA
Consultant
• As a QA Representative my role was to be a Liaison between Lonza and internal customer.
• Worked with internal customer QA representative on addressing Quality issues.
• Provide guidance on when a Change Control, Deviation and Protocol is required.
• Write deviations and provide Assistance to the deviation writer on additional investigation required.
• I reviewed and approved Change Controls, Deviations, CAPAs, OOTs, OOS, Batch Records, Solution Prep Records
and all internal customer related documents.
• As a QA Representative for Lonza’s internal customer I reviewed and dispositioned All raw materials (components)
used in GMP processes prior to use. I also was able to release raw materials for production or reject raw materials that
do not meet Lonza quality standards.
• As a QA Representative I performed routine GMP operations audits. All deficiencies are recorded, investigated, and
corrected.
• As a QA Representative I reviewed and approved All GMP documentation impacting my customer prior to
implementation.
• As a QA Representative I performed routine GMP training of all employees.
• As a QA Representative I performed Product Changeover, suite release audits and release from shutdown. I reviewed
protocols and paperwork and also audited my internal customer’s suites for product changeover, GMP release and suite
release from shutdown. While ensuring that all functions of Quality Assurance are consistently in compliance with
regulatory requirements and corporate standards.
AAQ Consulting and Service LLC. P.O. Box 678 • New City • NY • 10956 • ********@*****.*** 914-***-****
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Nkeiru Green, Quality/Compliance Scientist
• Assisted in Implementing and driving global complaint processes across all businesses.
• Drive accurate and timely closure of complaint investigations, deviations, CAPA, NCR and Change Control.
2011-2011 Client: Philips Healthcare, Cleveland
Consultant
• Retrospective review of class III devices within Philips healthcare.
• Retrospective review of CT (Computer Tomography ) manufacturing Defect Reports (DR) for 21 CFR Part 820
compliance
• Retrospective review of NM (Nuclear Medicine ) manufacturing Defect Reports for 21 CFR Part 820 compliance
• Retrospective review of PET/CT (Positron Emission Tomography ) manufacturing Defect Reports for 21 CFR Part 820
compliance
• Retrospective review of DR’s and its subsequent disposition for compliance with elements of FDA 21 CFR 820 to
include but not limited to design control, document control, nonconforming material, process and process control,
recordkeeping, ISO 13485, ISO 14971 Risk Management, Good Documentation Practice (GDP) and statistical
techniques
• Review all DR related procedures in PH, Cleveland site to ensure they are in compliance with all pertinent regulations
like 21 CFR 820 and ISO 13485
• Audit Manufacturing process and 19000 QN inputs in Access database
• Most importantly, created a positive impact on the client's mind set to further improve their quality.
• Ensuring that all functions of Quality Assurance are consistently in compliance with regulatory requirements
and corporate standards.
• Assisted in Implementing and driving global complaint processes across all businesses.
2010-2011 Client: Philips Healthcare, Best, Netherlands
Consultant
• Retrospective review of class III devices within Philips healthcare.
• Retrospective review of IXR (interventional X-Ray Systems) Quality Notifications for 21 CFR Part 820 compliance
• Retrospective review of MR (Magnetic Resonance Systems) Quality Notifications for 21 CFR Part 820 compliance
• Retrospective review of process CAPA for compliance
• Audit Manufacturing process and 11000 QN inputs in SAP database
• Created protocol, provided training both in grp setting and one-on-one coaching on key CAPA elements to ensure
understanding of FDA requirements.
• Performed adequacy review on completed elements and proposed changes to close gaps.
• Provide training for Quality Tech and Engineers on CAPA process, GMP, 21 CFR 820 and ISO 13485
• Most importantly, created a positive impact on the client's mind set to further improve their quality.
2009-2010 Quality Engineer II Complaints Investigation, Boston Scientific, Spencer, IN
• Provided leadership role on championing complaint investigation across functional areas within the facility.
• Provided project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigated, identified, and implemented best-in-class Quality Engineering practices.
• Established effective corrective action plans as they relate to complaint closures.
• Lead in implementation of quality assurance plans, and CAPA systems documentation to meet or exceed internal and
external requirements.
• Acted as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applied sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving
quality issues.
AAQ Consulting and Service LLC. P.O. Box 678 • New City • NY • 10956 • ********@*****.*** 914-***-****
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Nkeiru Green, Quality/Compliance Scientist
• Reviewed and approve product, process, software qualification and validation and other change control related
documentation of complaints file.
• Acted as an effective leader or team member in supporting product/process assurance plans, which include all required
elements. Identify and implement effective process control systems to support the development, qualification, and on-
going manufacturing of products to meet or exceed internal and external requirements.
• Generated internal quality documentation such as quality plans, standard operating procedures and inspection
procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.
• Participated in Product Review Boards. Identify non-conformance trends and develop technical investigation plans.
Investigated and analyze customer/internal complaints.
• Identified industry best practices. Act as an effective leader or team member in supporting quality disciplines,
decisions, and practices. Lead/actively participate in Barrier removal team activities (BRT).
• Utilized standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process
capabilities and assist Manufacturing Engineering and Process Development Engineering in setting drawing tolerances
(i.e. perform qualitative and quantitative data analysis).
• Exposed to Lean Management in and regulations pertaining to GMP/QSR, ISO9001/ISO13485/CMDR/CMDCAS/CE
and associated regulatory agencies.
• Ensuring that all functions of Quality Assurance are consistently in compliance with regulatory requirements
and corporate standards.
• Drive accurate and timely closure of complaint investigations, CAPA and NCR.
2008-2009 Client: Regulatory: Stryker Orthopaedics, Mahwah, NJ
Consultant
Major Accomplishments: Compliance / Reporting Analyst
• Created and initiate PER files transcribing faxed data into Complaint Database (Track Wise).
• Monitored complaints for product trends and notify management of events requiring immediate action.
• Followed up with, Patient’s, Sales Reps and hospitals to obtain applicable information pertaining to reported events.
• Corresponded with FDA office on additional complaint data and CDRH Letters.
• Obtain product function information in collaboration with engineers to determine reportability.
• Reviewed PERs for AE reportability to the FDA and other competent authorities under Medical Device Reporting and
Medical Device Vigilance Regulations (MDD).
• Ensured timely completion of MDR/MDV rationales and initial, supplemental and final incident reports to FDA and
other Competent Authorities within specified time frames.
• Monitored and trend MDR activity and prepare weekly status reports to management.
• Participated in continuous (breakthrough) improvement activity and process re-engineering projects in support of
Stryker Orthopaedics Business Process Excellence initiative.
• Maintained knowledge of applicable related Federal and Foreign regulations pertaining to Medical Device Reporting
through training, reading, etc Writes, reviews, and approves, as necessary, summaries of failure investigations and
complaint investigations.
• Assisted department with Recall letters and customer correspondence.
• Performed training for in-house and field personnel on PER and MDR reporting.
• Prepared ad-hoc reports of complaint and MDR trends.
• Provided MAUDE database searches and reports as required.
• All while ensuring that all functions of Quality Assurance are consistently in compliance with regulatory requirements
and corporate standards.
2006-2008 CAPA Coordinator, Fujifilm, Stamford, CT
• Responsible for FUJIFILM Medical Systems U.S.A., Inc. Complaint processing and reporting to assure the company’s
compliance with FDA QSR, and global standards.
AAQ Consulting and Service LLC. P.O. Box 678 • New City • NY • 10956 • ********@*****.*** 914-***-****
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Nkeiru Green, Quality/Compliance Scientist
• Worked with owners facilitates timely closure of Complaints, NCRs and Investigations.
• Responsible for the coordination of timely QRB meetings, investigation to root cause, and resolution of all complaints
and Non-conformance Reports (NCR) received.
• Initiated Investigation worksheets on behalf of Ex. Committee as a deliverable from Management Review, as well
QRB as needed.
• Initiated CARs for all internal requirements. Evaluates CAR worksheets and reconciles with CAR owners any
outstanding issues or shortcomings in the worksheet contents.
• Regular communications with CAR, NCR, and Investigation database administrator for FMEA updates, closures,
authorizations etc.
• Assisted in Implementing and driving global complaint processes across all imaging businesses.
• Drive accurate and timely closure of complaint investigations.
• Participated in Monthly CAPA meetings, and Bi-weekly QRB.
• Assisted Corrective Action Report (CAR) owners in the development of the corrective and/or preventive action plan to
assure it adequately addresses and resolves the complaint and/or complaint trend observed.
• Provided periodic trend analysis reports.
• Wrote, reviewed, and approved, as necessary, summaries of failure investigations and complaint investigations.
• Assisted in the investigative process by coordinating tasks across department lines.
• Reviewed complaint, investigation and NCR documentation for completeness of content prior to its submission to the
Quality Review Board.
• Monitor and trend complaint activity and prepare weekly status reports to management.
• Exposure to Lean Management in and regulations pertaining to GMP/QSR, ISO9001/ISO13485/CMDR/CMDCAS/CE
and associated regulatory agencies.
• Ensuring that all functions of Quality Assurance are consistently in compliance with regulatory requirements
and corporate standards.
2005-2006 Client: Wyeth Pharmaceutical, Pearl River, NY
Consultant
Major Accomplishments: QA Specialist
• Responsible for providing Quality Assurance support to Manufacturing, Validation, Engineering and Testing
Operations relative to the production of commercial and clinical products.
• Reviewed batch records and gives disposition (approval, rejection, etc.) to the material produced.
• Reviewed SOPs, protocols, analytical results and investigations associated with manufacturing operations in Database
(Track Wise).
• Responsible for a diverse and challenging activities, all of which are related to setting and maintaining quality
standards aligned with US FDA, cGMP and other applicable international GMP regulations and guidance.
• Have working knowledge of fundamental technical and quality concepts, applicable guidelines of the FDA or other
regulatory bodies and relevant Wyeth SOPs, and receives minimal supervision on routine assignments.
• Worked with project teams providing services to the manufacturing operations for Drug substance and Drug Product to
assure appropriate consistency in GMP systems applied across both clinical and licensed products.
• Inspected Raw materials for approval/rejection based on Acceptance Criteria.
1994-1997 USMC - Stationed at (RAC), Parris Island, SC
• Gave recruit-training classes.
• Record keeping, prepared graduation and promotion warrants.
• LAN accounts-Coordinated all messages and personnel accountabilities.
• Secretarial work including record keeping, labeling and filing.
• Receptionist at on-base receiving center.
AAQ Consulting and Service LLC. P.O. Box 678 • New City • NY • 10956 • ********@*****.*** 914-***-****
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Nkeiru Green, Quality/Compliance Scientist
DATABASE:
• Trackwise • •
Access Clearquest
• Agile • •
Clarity NetRegulus
• SAP • •
Lotus Notes CATSweb
EDUCATION
• Bachelors of Science, Biological Sciences, 2001, Rutgers University.
• Masters, Regulatory Affairs, 2013, Northeastern University.
• ISO 9001/2008 certified Lead Auditor
AAQ Consulting and Service LLC. P.O. Box 678 • New City • NY • 10956 • ********@*****.*** 914-***-****
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