Ramona James- Colton

**** **** ****** ****, *********, CA 92028 Phone: 951-***-**** Email: ad4p0c@r.postjobfree.com and ad4p0c@r.postjobfree.com

Summary

Over 15 years of experience in Complaint Management, Regulatory Compliance, Quality Specialist, Quality Assurance and Customer Service in the field of Medical Device Manufacturing. As a Certified Medical Assistant, I have 5 years’ experience working in OB/GYN, Fertility and Family Practice.

Education

ASSOCIATES OF ARTS APR 2010 UNIVERSITY OF PHOENIX

Health Care Administration

CERTIFIED MEDICAL ASSISTANT OCT 1993 PIMA MEDICAL INSTITUTE

Coursework: Anatomy, Physiology, Medical Terminology, Phlebotomy

Skills

Proficient with Outlook, Microsoft Suite, Teams, Excel, PowerPoint, Track Wise, Sales Force, SAP and other ERP systems

Professional Experience

THERMO FISHER SCIENTIFIC, CARLSBAD, CA QUALITY SPECIALIST II NOV 2021 - SEPT 2023

Responsible for opening and closing medical device complaints (IVD, RUO, OEM) using Good Manufacturing Practices.

Processed Medical Device Reports (MDR) and Vigilance reports (MDV).

Ensured all support documents were attached to complaint files in an organized manner.

Current with SOPs and Quality System training documents.

Proficient with 21 CFR part 820 and 803, ISO13485, IMDRF Coding, SAP, CAPA, PPI, member of BSI audit team

Assigned to stakeholders located in domestic and countries out-of-USA.

Received award: Global Services & Support Transformation Award for Quality Management System 2022

BECTON DICKINSON – CONTRACTOR: SAVIANCE TECHNOLOGIES APR 2019 – JUN 2021

TITLE: CLINICAL COMPLAINT MANAGEMENT SPECIALIST II

Collected complaint information from customers and determined reportability status for Regulatory Reporting. Verified serial and lot numbers for medical devices using SAP.

Processed regulatory reports including US MDRs, EU Vigilance, Canada, TGA, SFDA, and MHLW. Collaborated with OUS Competent Authority Affiliates. Prioritized work efficiently with no late reports.

IMDRF Patient and Device Coding, kept current with SOPs and Quality System training and practiced audit readiness with internal audits.

Reviewed and closed complaint files withing 45- 60 days. Reviewed Quality Engineering report to ensure device history record, root cause analysis and coding were correct for the reported complaint. Provided investigation report to the customer.

Participated on Peer Review team to ensure consistency and accuracy of complaint files.

WATKINS MANUFACTURING – CONTRACTOR: MANPOWER SEP 2016 – MAY 2018

CUSTOMER SERVICE REPRESENTATIVE AND COMPLAINT HANDLER

Answered and managed a high volume of telephone calls from customers and hot tub dealers.

Knowledgeable of water chemistry and day-to-day hot tub operation.

Performed data entry, answered questions, and provided warranty information.

Provided solutions to issues before they advanced to an escalated status. Managed escalated cases.

Multi-tasked (incoming and outgoing phone calls, processed spa part orders, prioritized tasks, and managed open cases, checked and responded to emails in a timely manner)

Reviewed and interpreted data to generate product and/or process documentation and updates for service technicians, Sales Managers, and other internal staff.

ABBOTT VASCULAR PRODUCT PERFORMANCE ANALYST AUG 2014 - JUL 2016

Evaluated incoming medical device complaints (Intake), determined the severity of reportability for US and other competent authorities (Canada, MHLW, TGA, SFDA, EU Vigilance, Mexico, ANVISA).

Coded adverse events and device malfunctions using FDA Patient and Device Coding system. Worked closely with Abbott Sales Representatives and reporting hospital medical personnel such as, catheterization lab technicians, doctors, nurses and hospital risk management to collect accurate information for accurate regulatory reporting.

Monitored high volume of open cases closely and closed cases in a timely manner.

Generated customer letters with the completed investigation report.

Proficient with 21 CFR part 820 and 803, 211, ISO13485

ABBOTT VASCULAR REGULATORY AND QUALITY ASSURANCE ASSISTANT OCT 2005 - AUG 2014

Assistant to 3 Product Performance analysts. Received and entered complaint information into database within 2 days from Aware Date.

Drafted regulatory and technical reports on regulatory reporting forms for USA and other OUS competent authorities.

Drafted customer letters (investigation reports)

Ensured that all support documents were attached to complaint files in an organized manner.

Keep current with SOPs and Quality System training requirements.

Proficient with 21 CFR part 820 and 803, ISO13485

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