PROFESSIONAL SUMMARY:

• Complaints/ Confidential Specialist with 15+ years of experience in the Quality Compliance industry and medical devices. Experience includes complaints investigation/handling, medical device record (eMDR) filings, CAPA, ISO and post - market surveillance.
• Professional Skills: Exemplary Cross-functional Team Leadership. Quality complaint investigations, electronic medical device reporting (eMDR) for patient serious injuries, adverse events and product malfunctions.
• Consistently compliant with all US FDA regulations ( Confidential regulation 21 CFR Part 11, 801, 803, 806, 811, 820 as well as ISO 13485) to ensure the highest level of quality while adhering to all compliance standards. Assistance with process improvement. Internal complaint auditing. Proficient with writing root cause investigation summaries.
• Coordinates and assists with corrective actions taken regarding product/quality system deficiencies (Recall, Advisory Notices, HHE, IE etc.) and the relevant notifications to Regulatory authorities. Review Product Complaint Evaluation for accuracy and completeness.

TECHNICAL SKILLS:

• SAP, Complaints Handling EtQ
• (Excellence through Quality)
• TrackWise Web-based
• Quality Management, PeopleSoft, COGNOS
• Crystal Reports, CatsWeb
• Complaint Handling Management Software
• JD Edwards, Oracle BI Discoverer
• Livelink, Enovia, MS Outlook, MS Office Suite

PROFESSIONAL EXPERIENCE:

Confidential, Palm Beach Gardens, FL

Sr. Product Surveillance Specialist, Medical Devices

Responsibilities:

• Responsible for evaluating whether a complaint is reportable to any regulatory authorities by completing the applicable decision trees. (i.e European, Canadian, Brazilian, Australian, and/or Chinese)
• Identifies complaint risk / investigation level based on reportability decisions made.
• Notifies investigators of reportability decision changes that would affect the investigation level initially established.
• Upon receipt of additional information which impacts the initial reportability decision, I will determine the affects of the initial reportability decision.
• Notifies country representatives of reported Confidential events that occurred outside of their country but involves products which are approved and registered in their country and their country. (i.e. Japan)
• Creates and reviews the Alternative Summary Report for submission.
• Performs independent reviews of completed Decision Tree(s) which determine that an event is not reportable.
• Responsible for providing for eMDR/MedWatch Report and Health Canada Vigilance - Medical Device Reporting Program.
• Evaluates any modification, revision and/or review of new complaint information for which a closed complaint may require reopening.
• Responsible for the maintenance of Reportability Guidance Document.
• Identifies new information that suggests a particular event not previously associated with serious injury, serious deterioration in state of health, or a death has caused or contributed to a serious injury, serious deterioration in state of health, or death.
• Distributes workload to applicable team members for eMDR / MedWatch, MEDDEV and Health Canada Vigilance submissions.
• Monitors the reportable event submissions queue inside of the QMS to prevent late reports submitted to the FDA and/or other countries Competent Authorities.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.
• Appointed interim-supervisor by the associate director within first 7 months of hire.
• Revised and trained employees on the reprotability guidance document use to help make reportability decisions.
• Was nominated by the associate director to the Confidential Impact .

Confidential, Dover, OH

Quality Consultant, Medical Devices, Quality Engineer Lead

Responsibilities:

• Performed a systematic review and remediation of overall Risk Management process to ensure compliance with EN ISO 14971:2012.
• Focus on both standard operating procedures as well as any currently existing risk management files.
• Each individual file will be reviewed to determine the level of remediation required in order to meet client’s Risk Management Procedure which includes applicable documentation such as Risk Management Plan, Hazard ID, DMFEA, PFMEA, Risk Benefit Analysis, Risk Management Report, Risk Management Meeting Minutes
• Nonconformance’s and complaints analysis will be performed for all products in the remediated RMF and will feed into risk management file analysis.
• Responsible for transferring information from legacy risk files to current templates and completing drafts of boilerplate docs such as risk management plan.
• Assist with risk remediation meetings, take meeting minutes, and coordinate with PM in tracking of open items
• QE will be involved with: RM Plan and Risk meetings, DFMEA, PFMEA (Including Hazard ID's), and potentially other RMF documents

Confidential, Warsaw, IN

Quality Consultant

Responsibilities:

• Adhered to all corporate and site specific procedures.
• Identified and investigates solutions to procedure and process related issues. Revises the procedure or process as needed to increase efficiency and compliance.
• Evaluated complaints to determine whether an adverse event report/Medical Device Reporting ( Confidential ) is in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements.
• Ensured that incident reports to US European and International NCAs are submitted within the regulatory timeframes. Documents rationale if incident reports are not required.
• Assesses decision tress for reportability in the system and documents review/approval.
• Determined what information are required and complete Confidential Decision Trees and other decision trees to assess reportability to the FDA and other regulatory bodies, such as Europe, Canada, Brazil and Australia.
• Reviewed and approves incident reports ( Confidential, MDV, etc.) upon adverse events and ensures all follow-up and final reports to US, European and International NCAs are completed.
• Assessed and verifies that all actions needed to complete the complaint handling process have been completed accurately and completely.
• Worked with the Product Surveillance Coordinators and Investigators to ensure all data is accurate, the appropriate reportability actions have been completed and all information is entered into the complaint record.
• Verified that responses to standard and extended requests from Competent Authorities are accurate and approve the requests.
• Provided direction to internal and external personnel on issues related to product experience reporting, complaints and adverse event reporting.

Confidential, West Palm Beach, FL

Quality Consultant

Responsibilities:

• Reviewed and drafted initial MDRs to ensure all adverse events were properly reported via EtQ database.
• Under the guidance of more senior quality systems specialist, assist in conducting audits or remediation against FDA, ISO, and/or other international laws and guidelines as required.
• Documented audit results and coordinate the resolution of subsequent CAPA actions.
• Worked with company personal to ensure all QMS documents and records are compliant to required standards.
• Maintained current knowledge of FDA requirements for medical devices.
• Followed required policies and operating procedures associated with your assigned responsibilities.
• Investigated potential compliance issues and keep management informed of findings.
• Diligently participate in our compliance program-related activities as requested by the Quality Systems Manager or Chief Compliance Officer.
• Performed special projects and other duties as assigned.
• Provided a quality review and assessment of complaint closure activities.
• Escalated issues and potential solutions to management team.
• I was one of five consultants chosen to assist the client with the backlog of open complaints provide Confidential support services, document audit results and coordinate the resolution of subsequent CAPA actions.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.

Confidential

Quality Consultant

Responsibilities:

• Written and filed initial and supplemental Medical Device Reports in timely submission to the FDA.
• Responsible for manual and eMDR submissions via eSubmitter (creation of new Confidential drafts within 3500A MedWatch Forms in zip file format) and WebTrader (upload zip file in Electronic Submission Gateway (ESG) of final Confidential drafts upon final review).
• Responsible for receiving all electronic receipts and acknowledgements in ESG WebTrader account.
• Developed and maintain Confidential daily submission logs of medical device reports to the FDA.
• Distribution of daily assignments from FDA 30 Day Report.
• Provided Confidential reviews and approvals for all team members of seven manufacturing sites.
• Provided for writing, reviewing and proper submission of Confidential reports to the FDA for timely submission.
• Consistently compliant with all US FDA regulations to ensure the highest level of quality while adhering to all compliance standards.
• Consistently exceeded daily targets for supplemental Confidential ’s while completing reports effectively in a timely manner.
• Coordinated and conducted meetings with team members to meet group and organizational goals.
• Maintained follow-up information pertaining to patient events and complaint investigations with internal and external quality personnel to fulfill daily tasks that are critical to proper Confidential submissions.
• Communicated with management on team’s progress and follows the team’s established goals through to execution.
• Reviewed and adhered to complaint handling regulations in 21 CFR 820 and 803 as well as ISO 13485.
• Daily interaction with various internal customers to assist with evaluating reportable complaints for investigation path.
• Ability to understand the potential implications of medical device malfunctions or failures and how they might impact patients or users.
• Appointed an Confidential Team Lead by the associate manager within the first two weeks of hire date.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.

Confidential, West Palm Beach, FL

Quality Consultant

Responsibilities:

• Assisted in remediation activities associated with internal or external audit findings.
• Review and draft initial MDRs to ensure all adverse events were properly reported via EtQ database.
• Under the guidance of more senior quality systems specialist, assist in conducting audits or remediation against FDA, ISO, and/or other international laws and guidelines as required.
• Document audit results and coordinate the resolution of subsequent CAPA actions.
• Work with company personal to ensure all QMS documents and records are compliant to required standards.
• Maintain current knowledge of FDA requirements for medical devices.
• Follow required policies and operating procedures associated with your assigned responsibilities.
• Investigate potential compliance issues and keep management informed of findings.
• Diligently participate in our compliance program-related activities as requested by the Quality Systems Manager or Chief Compliance Officer.
• Perform special projects and other duties as assigned.
• Provide quality review and assessment of complaint closure activities.
• Escalate issues and potential solutions to management team.

Confidential, Indianapolis, IN

Confidential Specialist

Responsibilities:

• Reviewed and submitted Confidential ’s to the FDA and assigned tasks to agents for correction and/or additions required by FDA guidelines. Also submitted reportable Confidential ’s to the FDA in a timely manner as required by FDA guidelines.
• Provide for new hire agents and provided updated for current agents for any potential updates to current Confidential criteria.
• Provide for new hire agents and current Pump Support agents for Confidential criteria and any potential updates to current Confidential criteria.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.

Confidential, Indianapolis, IN

ACC Service Representative

Responsibilities:

• In this position I was responsible for answering inquiries concerning the entire RDC Diabetes Care Product Line including Self-Blood Glucose Monitoring Systems and Data Management products.
• The Customer Care Specialist (CCS) provides troubleshooting steps in the resolution of customer concerns
• The CCS also educates the customer in the successful use of RDC products.
• The CCS also provides marketing information reinforcing the positioning of a product.
• Demonstrated competence in interactive communication, problem solving, and decision making ability to successfully handle irate customers, and demonstrated ability to develop and verbally describe a logical sequence. Ability to develop a broad knowledge of diabetes, blood glucose monitoring, laboratory methods, legal and regulatory issues.
• Experience with inputting customer information and logging calls in SAP system.
• Experience with gathering, logging and submitting Confidential ’s.
• Served as a Confidential liaison since August of 2006.
• Assisted with reviewing submitted Confidential ’s and assigning tasks to ACC agents for correction and/or additions required by our Regulatory partners.
• Consistently received the maximum monthly bonus for the “Very Outstanding and Beyond Requirements” work provided to our patients.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.

Confidential

Pump Support Specialist

Responsibilities:

• Provided technical assistance and troubleshooting to existing Disetronic patients, Physicians, CDE, sales representatives, marketing, distribution personnel and others for insulin pumps, software and ancillary supplies.
• Document call details in database to ensure compliance, ensure shipment and receipt of replacement products.
• Assessed product situations to identify potential Confidential 's.s:Created Quality Assurance Form for Disetronic Pump Support New Employee Class.
• Created Work Instructions and Standard Operating Procedures that Confidential currently utilizes.
• Maintain Confidential submissions to the FDA in a current status on a continual monthly basis.