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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 CurrentSenior Manager, Medical Device SafetyBristol 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 05/2020Complaint AnalystPace 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 03/2018Medical Device TechnicianMallinckrodt 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 03/2015Electronic 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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