For Prof tutor only******

(NAME)

(Address)

OBJECTIVE

Seeking quality or regulatory environment where my knowledge and experience can be shared and enhanced. Looking for an opportunity where I can improve as well as contribute my knowledge and technical skills in the organization. I want to use my knowledge in the medical device and pharmaceutical industries to further my experience as a post market surveillance, regulatory and quality engineer.

SUMMARY OF QUALIFICATIONS

• Medical Software/ Quality Systems: Agile, GE Centricity, SAP, CatsWeb, ETQ, JDE, Pilgrim- Smart Solve, TrackWise, Oracle Applications, Iron Mountain, QAD, CEBOS

• Other Software: Microsoft Office, IBM Lotus Notes, AutoCAD, ProE, Price Manual

• Knowledge of FDA regulations (21 CFR 210, 211, 803, 820, 820.198, and 820.200), and ISO standards (13485) – Quality Management Systems

• 510k submissions for new devices

• Experience with device and pharmaceutical investigations, root cause analysis, health hazard evaluations and corrective action preventive action (CAPA)

• Experience with Class I, II and III Medical Devices (single-use, reusable and capital equipment)

• FDA: MedWatch 3500A/eMDR, Adverse Drug Events (ADE), and Alternative Summary Reporting (ASR)

• International reporting: MDV and BSI (European Economic Area), MDPR (Canada), PMDA (Japan) and TGA (Australia)

• Experience working under 483 Observations and FDA Consent Decree

• Bilingual: English and Spanish

PROFESSIONAL EXPERIENCE

ALKU Consulting

HeartWare, Inc. a Medtronic Company

Quality Clinician, CAPA Failure Analysis Engineer and SME

December 2015- present (Miami, FL)

• Responsible for conducting failure analysis investigations in accordance with the requirements established in the Complaint Management Procedure and applicable Work Instructions. Responsible for documenting failure analysis investigations in a manner which provides clear rationale that supports conclusions. Identify additional functional support to complete the failure analysis investigation. Escalate reported issues per standard operating procedure - Issue Escalation, Decision and Action - Distributed Product, Corrective & Preventive Action (CAPA) Process if a confirmed event code requires action to prevent recurrence of a potential manufacturing, design, packaging, or labeling issue.

• Responsible for reviewing initial and additional information received for complaints and determines whether a Failure Analysis Investigation is required. If the information available within the complaint file reasonably suggests that the mechanical component(s) involved in the reported event failed to meet design, manufacturing, labeling, and/or performance specifications, a Failure Analysis Investigation should be requested regardless of the Tier level of the investigation. Responsible for reviewing, evaluating and investigating complaints for a Class III Ventricular Assist Device (VAD) for Congestive Heart Failure Management. As a Complaint Handling SME I prepare and submit MDR’s, and MDV’s, also report to MDPR, PMDA, and TGA. As a QA Clinician, I conduct deep dive investigations for particular complaint cases, write clinical narratives, assign applicable event severity and assess whether the event is reportable.

• Process validation for new equipment’s for manufacturing batteries. Authored, Executed & Completed validation protocols (e.g. URS, DQ, IQ, OQ, PQ) to prepare for FDA inspections and manufacturing activities relating to 21 CFR 211, 21 CFR 820. Authored initial drafts and final versions of other cGMP documents (e.g. SOPs, Training Documents, Change Requests, Work Orders, Calibration and Preventive Maintenance Forms). Validated relocation of testing equipment to the Netherlands, calibrated all laboratory and bench testing equipment for peripheral Class III devices.

• Provided assistance to Clinical Engineering with transition to European Medical Device Regulation (MDR). Gathered trending data, historical records from a failure analysis point of view for regulatory risk documentation. Under the new regulation for a Class III medical device the organization was required to collect post-market clinical data as part of their on-going assessment of potential safety risks.

EG Life Sciences Consulting

Merge Healthcare an IBM Company

Regulatory and Quality Specialist

December 2015- April 2016 (Remote-Work from home)

• Interpret the regulatory precedents (21 CFR 606, 210/211, 803, 807, 820 and other statutory requirements), global standards, and new legislation; develop the regulatory approach; conduct communications with authorities; execute an effective path to approval; select appropriate manufacturing vendors/suppliers; CAPA investigations; compliance oversight for software-embedded/COTS devices; deliver customized training; and provide clinical trials and compliance support for clients with CRO/CMO; remediate CAPA systems, EV criteria and best practices workflow with CAPA automated routing, notification, approval, and escalation.

• Establish a compliant Design Control and risk management system; ensure overall strategy compliance with QSR and international standards, including ISO 14971/13485; FDA registrations; and conducted audits/assessments.

• Responsible for reviewing and submitting reportable events to the Food and Drug Administration. Made clinical decision based on decision tree provided by the client.

• Approved 3500A forms for closure of complaint investigations. Finalized closure and electronic submittal also known as eMDR directly to the FDA.

• Developed a Health Hazards, Harms and Severity matrix for all devices for Regulatory purposes. Labeled Severity rating based on historical events with an initial severity rating and actual severity for each potential malfunction.

Oxford Consulting

Covidien a Medtronic Company

Post Market Clinical and Pharmacovigilance Analyst – Team Lead

June 2015- December 2015 (New Haven, CT)

• Responsible for reviewing, evaluating and investigating complaints relative to the identity, quality, reliability, safety and effectiveness of assigned Surgical Solutions products.  As a PMV Team Lead Analyst I provided clinical expertise in the oversight of products in order to assess patient safety/harm.  In addition, I was responsible for leading a team in the handling/categorizing of complaints to comply with current FDA and international reporting regulations.  My duties also included compliance tracking, trend analysis, preparation of Health Hazard Evaluations, preparation of correspondence with government agencies, and reporting to Management. I responded to all medical inquiries related to complaints, as well as assisted in analyzing specific operative use issues related to the Surgical Solutions products.

• Determined reportability (MDR/AE) of complaints to FDA and other international regulatory agencies, including but not limited to European, Japanese, Australian, and Canadian regulatory agencies. Worked closely with the Medical Director of Patient Safety to establish standards for detection of patient harm. Reviewed, tracked, trended, analyzed and reported on complaint data to Management and other departments as needed. Worked with cross-functional teams to ensure proper communication and evaluation/investigation of customer issues. Took lead on specific CAPA complaint issues and coordinated with other departments to initiate and further investigate root cause. Created responses to requests for additional information from government agencies.

Black Diamond Networks Consulting

ConvaTec

Post Market Clinical and Pharmacovigilance Specialist – Quality Engineer

January 2015- July 2015 (Greensboro, NC)

• Responsible for reportability decisions and processing adverse event complaints. Medical device and pharmaceutical reporting for complaint files that were open and closed. Provide dsupport for FDA audit, inspections and internal corporate audits

• Initiate complaint investigations through TrackWise. Responsible for using scientific knowledge, experience, and training to write investigations as per the Nonconformance and Corrective and Preventive Action (CAPA) processes and systems across the site and multiple product lines. Responsible for ensuring that nonconformance investigations meet specification as per client validated procedures, specifications and regulatory requirements (21 CFR 820 and ISO 13485)

• Maintain and analyze nonconformance and CAPA data in a global environment, including trend and root cause analysis. Identify potential quality problems using recognized problem solving techniques, communicate issues to the Operations and Quality management, aid in determining causes and subsequent corrections and/corrective actions. Generate and write nonconformance reports for each nonconforming event and notify the appropriate client personnel

Validant Consulting

Fresenius Medical Care

Post Market Clinical and Pharmacovigilance Specialist

May 2014- December 2014 (Waltham, MA)

• Medical device and pharmaceutical reporting for complaint files open or closed, determine reportibility for complaints filed

• Organize pertinent information for MDR and ADE forms and apply proper codes to facilitate decision and closure

• Review Device History Records to verify production specifications and product accountability

• Investigate information provided by facilities that use Fresenius Medical Devices and have reported product related complaints to the complaint handling department

• Review returned product complaints, supply root cause and applicable corrective action

• Asses adverse events that occurred to patients while using or on treatment of the Fresenius Medical Devices associated with their Dialysis treatment. Analyzed data for trending purposes on complaints, and determined troubled areas to tailor project needs

• Finalized project and was included on the CAPA commitment to the FDA and submitted final written response of project completion to the agency

Maetrics Consulting

Depuy Synthes a Johnson & Johnson Company

Associate Compliance and Quality Engineer

September 2013-May 2014 (West Chester, PA)

• Approved 3500A forms for closure of complaint investigations. Finalized closure and electronic submittal also known as eMDR directly to the FDA

• Submitted expedited reports such as 5-day reporting and 30 day reports that required remedial action and reports that the FDA designated as a priority to report. Quality analyst in the field of medical device reporting; knowledge of FDA coding and regulations. Experienced in team management and leadership, medical device reporting, complaint handling, CAPA, adverse event handling, and severity determination

• Study technique guides and compared historical records to address trends of events occurring to all medical devices in the Trauma, Spine, and Craniomaxillofacial divisions. Collecting thorough information about complaints pertaining to quality/function of medical devices and organizing said info in a manner that facilitates FDA report ability decisions. Prepared and submitted Medical Device Reports. Provided one-on-one, hands-on training to new employees; small group training; and serving as a primary source of assistance for colleagues in addressing unique and difficult circumstances.

Medtronic Inc.

Team Lead for Health Insurance Verification Team & MDR Team

May 2010-September 2013 (San Antonio, TX)

• Provide assistance with escalated calls as a tier one employee; this helps the business with retention and de-escalation of disgruntled patients and professionals

• Initiate complaints in SAP per Medical Device Reporting guidelines as mandated by the Food & Drug Administration Follow up with patients with their medical device replacements. After initiation, I assist with further reporting to our technical support department

• Provide training to other consultants for the Paradigm insulin pumps and Guardians, disposables, Continuous Glucose Monitoring systems, disposables, Care link Personal and Professional, GE Centricity and SAP

• Assisted with a worldwide recall of disposable medical devices

• Responsibilities as a team lead include mentoring and coaching insurance verification specialist in both the Supply Order Sales and Pump Order Sales department to insure they meet guidelines for insurance companies

EDUCATION

• School One                                                      

Degree One

• School Two

Bachelor of Science in Healthcare Management

Master of Science in Healthcare Administration

Master of Business Administration

2017 Graduate