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JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary

Experienced Quality Professional with a demonstrated history of working in the Medical Device, and Pharmaceutical, and Biotech industry, with a foundation in the United States Military. Skilled in Pharmaceutics, Medical Devices, Regulatory Affairs, Electrical and Mechanical Troubleshooting, and Data Analytics. Dedicated to education, team emersion, and communication.

Skills
  • Quality System Regulations
  • Project Implementation
  • Microsoft Office
  • Problem Solving
  • Automated Planner
  • Data Analysis
  • Process Improvement
  • Regulatory Affairs
Work History
06/2020 to Current Senior Manager, Medical Device Safety Bristol Myers Squibb | Guaynabo, PR,
  • Responsible for the implementation of trending methodologies, processes, and standard procedures
  • Make recommendations based on integrated trending analyses and generate presentations in collaboration with program teams
  • Accountable for the production and accuracy of medical device analysis, interpretation of results and content contributions to Post-Marketing Surveillance (PMS) and Vigilance activities
  • Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance
  • Responsible for the orchestration of PMS program activities under the ownership of Pharmacovigilance (PV) MDS
  • Support standardization of database structures and implement standard processes required for integrated trending activities
03/2018 to 05/2020 Complaint Analyst Pace Life Sciences | Bremerton, WA,
  • Processed, maintained, and triaged Product Quality Complaints (PQCs) for the Cellex Photopheresis (Class III), and INOmax (Class II) Nitric Oxide product lines through Quality Management System (QMS) and SAP
  • Supported Quality and Engineering projects (CAPA, Change Controls, Non-Conformance Material Reports (NCMRs), and audits)
  • Reviewed and analyzed Contract Manufacturer Organizations (CMOs) investigations , improvement plans, and Batch Record Reviews (BRRs)
  • Prepared and submitted Adverse Event (AE), and Medical Device Reports (MDRs) to FDA and foreign government agencies
  • Aided Product Support, Field Service, Research & Development (R&D), and Customer Care departments with tracking and trending, and feedback reports of medical device conditions
  • Wrote, revised, and updated project manuals, Standard Operating Procedures (SOPs), and technical documentation used by the Product Monitoring, and cross-functional teams
  • Gathered data on integration issues and vulnerabilities and report all findings, including improvement recommendations
  • Developed and audit practices, programs, and metrics reporting systems to ensure optimal efficiency in accordance with FDA regulations, ISO 13485, ISO 14971, ISO 9001, and new EU MDR regulations
  • Performed root cause analysis for product return, and service complaint investigations for US and OUS complaints
  • Collaborated with team members, and pharmacovigilance department to prepare for new regulatory requirements
04/2015 to 03/2018 Medical Device Technician Mallinckrodt Pharmaceuticals | City, STATE,
  • Designated Representative in absence of Regional Service Center (RSC) Manager
  • Performed quality checks, acceptance protocol testing, preventive maintenance, and complaint troubleshooting for the INOmax medical device in accordance with CFRs (21 CFR 803 and 21 CFR 820), SOPs, and cGMPs
  • Instructed and trained junior medical device technicians and warehouse distribution personnel
  • Entered test result information, MDR findings, and customer feedback into SAP
  • Kept optimal quality levels to prevent critical errors and support team performance targets
  • Identified and resolved process issues to encourage smoother procedures, more efficient workflow and overall business growth
  • Authored all NCMRs for the RSC with regards to hazardous material, and new inventory
  • Improved quality processes for increased efficiency and effectiveness
  • Analyzed technical drawings and manufacturers' instructions to troubleshoot problems in functional and control systems
  • Analyzed test data to determine performance and reliability of materials
  • Determined proper corrective actions to bring products in line with requirements.
04/2013 to 03/2015 Electronic Technician (Navigation) United States Navy | City, STATE,
  • Coordinated in the organization of weekly and monthly maintenance meetings
  • Led newly enlisted sailors in delivery of pre-deployment mapping and navigation project requiring close cooperation among multiple divisions within the command
  • Evaluated ongoing work to check progress and maintain pace against schedule demands
  • Documented meeting minutes and distributed to staff to facilitate follow-up
  • Managed and archived quality documentation and participated in internal and external quality audits
  • Kept archive of critical ship's data logs, workflow logs, and watch logs
  • Completed the reorganization of the ship's nautical chart system, which resulted in future ease of use
Education
Expected in Bachelor of Business Administration | Felician University, Rutherford, NJ, GPA:
Expected in Associates of Business Administration | Middlesex County College, Edison, NJ, GPA:
Certifications

American Society for Quality (ASQ) – Certified Quality Process Analyst (CQPA)
Issued October 2019 | ID: 3365

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Resume Overview

School Attended

  • Felician University
  • Middlesex County College

Job Titles Held:

  • Senior Manager, Medical Device Safety
  • Complaint Analyst
  • Medical Device Technician
  • Electronic Technician (Navigation)

Degrees

  • Bachelor of Business Administration
  • Associates of Business Administration

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