Senior Manager, Medical Device Safety Resume Example
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SENIOR MANAGER, MEDICAL DEVICE SAFETY
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
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Work History
Senior Manager, Medical Device Safety, 06/2020 to Current
Company Name – City, State
Company Name – City, State
- 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
Complaint Analyst, 03/2018 to 05/2020
Company Name – City, State
Company Name – City, State
- 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
Medical Device Technician, 04/2015 to 03/2018
Company Name – City, State
Company Name – 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.
Electronic Technician (Navigation), 04/2013 to 03/2015
Company Name – City, State
Company Name – 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
Bachelor of Business AdministrationFelician University - City
Associates of Business AdministrationMiddlesex County College - City
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
