Quality Engineer Medical
Resume:
Kari M. Pilot
Princeton Texas 75407
512-***-**** (Cell)
*********@*****.***
QUALITY ASSURANCE
PROFILE
Quality oriented professional with extensive experience performs risk assessments and analyses, data analyst and tracking & trending. Areas of expertise include in medical device, marketing and customer relation buildings. Astute, analytical, resourceful, with proven ability to solve complex problems in a fast-paced environment; adhere rigidly to all GMP policies and procedures as stipulated by the FDA.
QUALIFICATION HIGHLIGHTS
Results oriented and dependable professional with 16 years of experience in all aspects of quality assurance
Managed Non-conforming area with-in the Sustaining Engineer Manufacturing department
Discipline and well organized in work habits with ability to identify problems and implement effective solutions
Perform failure analysis for complaints, as necessary.
Communicate directly with patients and physicians as required during the investigation of customer complaints.
Complaint review/ Reportability decisions to include timely submission of applicable adverse event reports (MDRs/ADEs).
Responsible for receiving, reviewing, and investigating adverse events
Participates in internal/external Quality Assurance/Regulatory Audits and communication of audit results.
Responsible for assuring the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to Domestic and/or International regulatory requirements such as DOH, ISO, GMP and other FDA regulations
Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting for US including EU, Canada, Australia and Japan.
Familiar with ISO Regulations 14971, 13485
Trained employees on updated policies and procedures
Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors
Develop and maintain excellent customer relationship with external and internal customers
Prepares monthly PERC metric reports for shareholder meeting
Inventory management software: JDE, IFS and DCS
Microsoft: Word, Excel, PowerPoint,AS400, CATSWeb, Pilgrim, Trackwise, Salesforce (One EMS), Service Max, Quest, EPIC, Enovia, IBM Cognos, Quality Management System EtQ Reliance Database, Oracle, LiveLink, SAP and Aquarius Imaging System
PROFESSIONAL EXPERIENCE
Quality Engineer Post Market Surveillance (Remediation Consulting) March 2020- July 2020
Philips Medical Systems (L &T Technology Consulting)
Receive Product Complaints from corporate Global Products Safety Complaints (GPSC) within the Complaint Trackwise System.
Perform timely Product Complaint Investigation per Philips policy and Regulatory requirements and performed historical reviews.
Follow-up with Field Service Engineer to obtain additional information to complete investigations on complaints.
Review reports of customer complaints and assess them for regulatory reporting.
Coding compliant records.
Compliant Investigator Post Market Surveillance Intake (Remediation Consulting) August 2019-March 2020
Allergan (Validant Consulting)
Take incoming calls from Physician and patient regarding recall breast devices
Creating and updating compliant files for potential adverse events
Order Breast Implant devices for Physicians using SAP
Create claim records relating to complaint files
Request payments for Physician and patients in Trackwise system
Compliant Investigator Post Market Surveillance (Remediation Consulting) September 2018-December 2019
Philips Medical Systems (R&Q Consulting)
Receive Product Complaints from corporate Global Products Safety Complaints (GPSC) within the Complaint Trackwise System.
Perform timely Product Complaint Investigation per Philips policy and Regulatory requirements and performed historical reviews.
Follow-up with Field Service Engineer to obtain additional information to complete investigations on complaints.
Review reports of customer complaints and assess them for regulatory reporting.
Quality Engineer Post Market Surveillance (Remediation Consulting) February 2018-July 2018
Beckman Coulter (Validant Consulting)
Review reports of customer complaints and assess them for regulatory reporting
Research complaints in GCAPA/Smartsolve for duplicate complaint records.
Create new complaints for further investigation.
Quality Engineer Post Market Surveillance (Remediation Consulting) November 2017-March 2018
Terumo BCT (Alku Consulting)
Review reports of customer complaints and assess them for regulatory reporting
Follow-up with service representative to obtain additional information to complete investigations on complaints
Update complaint records for closure using SAP database.
Provide feedback to peer and closing complaint files.
Provide trending history on similar complaints.
Quality Engineer Post Market Surveillance (Remediation Consulting) April 2017-December 2017
LivaNova (EG Life Sciences)
Review reports of customer complaints and assess them for regulatory reporting
Follow-up with service representative to obtain additional information to complete investigations on complaints.
Investigate and perform DHR.
Compiles data, generates and submits Medical Device Report (MDR).
Quality Engineer Post Market Surveillance (Remediation Consulting) September 2016-March 2017
Zimmer BioMet (Maetrics)
Review reports of customer complaints and assess them for regulatory reporting.
Follow-up with service representative to obtain additional information to complete investigations on complaints.
Investigate and perform DHR.
Complies data, generates and submits Medical Device Report (MDR).
Review deviation for any discrepancy.
Quality Engineer Post Market Surveillance Lead (Remediation Consulting) February 2016-August 2016
Zimmer BioMet (US Tech Solution)
Create reports for Postmarket Surveillance Plan (PSP) products that are due for review. Providing a brief summary for recalls, include the product, date, status, recall number, country, description of event, and corrective action.
Perform investigation and update deviations as needed.
Provide data that is needed for products registration renewal per Country.
Gather Reportable Complaints, Sales History, Recalls, and CAPA data and generate reports to identify the history of the products for Marketing History Review (MHR).
Review field action and MDRs to complete report.
Quality Engineer III Post Market Surveillance (Remediation Consulting) August 2015-December 2015
Philips Medical Systems (Black Diamond)
Receive Product Complaints from corporate Global Products Safety Complaints (GPSC) within the Complaint Trackwise System.
Perform timely Product Complaint Investigation per Philips policy and Regulatory requirements and performed historical reviews.
Follow-up with Field Service Engineer to obtain additional information to complete investigations on complaints.
Performed Risk Analysis and Trending Evaluation.
Post Market Surveillance MDR Specialist (Remediation Consulting) February 2014-August 2015
Fresenius Medical Care (Validant)
Active participant in the remediation of an FDA warning letter and Observation 483 observations.
Helps provide customer support and serve as a liaison between manufacturing facilities, the medical department, and customers/patients regarding adverse events and potential product problem.
Research device and patient information received from healthcare professionals regarding harm and potential harm to patient by FMCNA manufactured devices; compile data to Open/Close Product complaints.
Compiles data, generates and submits Medical Device Report (MDR) and Adverse Drug Experience (ADE) reports to the FDA as required.
Review field service order for any patient involvement determines if complaint is reportable or non-reportable.
Create Product Compliant Investigation Form for low severities complaint identifying the related CAPA/Group numbers and investigation summary.
Review/Code potential product complaints using Master Symptom Code and Severity list, Master Harms list on Actual Harm/Severity with respect to cause and contribute to patient safety.
Collaborate, review and execute MDR/ADE decision tree (Reportable or Non-reportable), 3500A MedWatch and product investigation.
Post Market Surveillance Specialist (Remediation Consulting) October 2012-February 2014
St. Jude Medical (Aerotek)
Review incoming service order to determine if service is a complaint or non- complaint.
Follow-up with field representative and patients to complete investigations on complaints.
Document the events and findings of complaint investigations logically.
Investigate device history records for non-conforming product throughout the complaint investigation.
Compiles data, generates and submits Medical Device Report (MDR) and Adverse Drug Experience (ADE) reports to the FDA as required.
Review Device History Record for findings of any discrepancies during initial built.
Active participant in the remediation of an FDA warning letter and Observation 483 observations.
Quality Assurance Analyst April 2004-July 2011
Zimmer Spine (formerly Abbott Laboratories Spine Division)
Independent judgment and decision making to determine appropriate action.
Submits data trends and outcome assessments; develops new measures as appropriate.
Analyze incoming non-conformance discrepancies. Disposition and drive corrective action as necessary by communicating issues to suppliers.
Review Device History Record for findings of any discrepancies during initial built.
Performed risk assessment on nonconforming devices.
Coordinates the Corrective Action and Preventive Action (CAPA) system and maintains a database follow-up system.
Update procedures and work instructions.
Follow-up with field representative and patients to complete investigations on complaints.
Provide quality guidance to 10 employees to ensure that the policy and procedure are followed during the initial built and inspection of devices.
EDUCATION
Bachelor of Business Administration
Concentration Marketing
American InterContinental University, Graduated August 2008
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