Dhara Gabriela Gutierrez Contreras
Baxter
Tijuana
1
Language
4
years of professional experience
Quality professional with experience in Post-Market Surveillance (PMS) within the medical device industry.
Experienced in product complaint handling and evaluation, analysis of device malfunction events, and assessment with regulatory requirements and Quality System (QMS) standards. Skilled in data analysis to support decision-making, regulatory compliance, and cross-functional collaboration to ensure patient safety, product quality, and continuous process improvement.
Work History
Assoc Quality Product Surveillance
3 Years 4 Months- Manage potentially reportable event workflows and evaluate complaints within complaint handling systems, assessing events based on product malfunction risk and regulatory reporting requirements.
- Conduct preliminary complaint assessments, identify product performance issues, and coordinate engineering investigations to determine root causes of reported malfunctions.
- Analyze reported events to identify potentially reportable incidents and support timely regulatory decision-making.
- Ensure timely and accurate closure of customer complaints in compliance with FDA, MDR, and applicable regulatory requirements
- Manage customer complaint records with a focus on Technical Support evaluations, ensuring complete and accurate documentation.
- Support internal audits by providing complaint handling documentation, responding to audit requests, and assisting with compliance-related activities.
- Ensure complaint records accurately reflect customer allegations, investigation findings, risk assessments, and final conclusions in accordance with quality system requirements
- Prepare and analyze priority complaint reports and performance metrics to support operational effectiveness, trend monitoring, and management decision-making.
Internship
4 Months- Analyzed data, calculated results, and registered environmental emissions to ensure compliance with regulations in Tijuana, Baja California.
- Evaluated documentation submitted by companies for environmental license renewals.
- Updated annual operational certificate for compliance (Annual Operational Certificate) and database of registered companies.
Education
Chemical Engineering
Skills
Manage of ISO 9001
ISO 14001
ISO 45001 and FDA-QSR’s ISO 13485
FDA 21 CFR Part 820
Quality Management Systems (TrackWise
SAP
ETQ)
Microsoft Skills (Office Word
Excel
Power Point)
Risk management
Regulatory affairs knowledge
Post-market surveillance experience
Continuous Improvement Certification
LANGUAGES
English : C1 Advanced (80%)
Timeline
Assoc Quality Product Surveillance
Baxter
04.2023 - CurrentRead More
Internship
Air Quality Laboratory
08.2022 - 12.2022Read More
Universidad Autonoma De Baja California (UABC)
Chemical Engineering
Read More
Soft Skills
- Analytical skills
- Attention to detail
- Problem-solving
- Ability to adapt to changes
- Organizational Skills
- Teamwork
- Effective communication
- Critical Thinking