Kimberly Getzel Cuevas
Summary
Motivated, positive with exceptional verbal and written communication skills. Invests passion and commitment to achieve corporate vision. Applies analytic methodology and latest technology to lead change and tackle new projects and ideas.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Supplier Quality Engineer
Medtronic
10.2023 - Current
- Involved in implementing new products into the SQM program at Medtronic, resulting in significant cost and time reductions in quality inspection.
- Ensure suppliers are well-trained on SQM systems, aligning seamlessly with inspection plans to ensure robust quality assurance.
- Collaborate effectively with Medtronic site SQEs to establish strategic partnerships with suppliers for essential Test Method Validations.
- Responsibilities also encompass meticulous record creation and documentation release using Agile MAP, along with organizing files in the ASL-Supplier system.
- Provide valuable project support by leveraging operational knowledge to contribute to the development and implementation of detailed guidelines and procedures.
- Strengths include adept monitoring of program/system status and compiling insightful information for comprehensive reports.
QA/RA Associate Analyst
Baxter
10.2020 - 10.2023
- Take on a leadership role in overseeing the entire process for three product lines at Baxter International, including complaint analysis and resolution.
- Demonstrated commitment to ensuring that complaints are resolved promptly and efficiently, aligning with stringent regulatory standards and compliance requirements.
- Proactively identify potentially reportable events and promptly notify the Medical Devices Reporting department, ensuring timely and compliant reporting in accordance with regulatory mandates.
- Actively collaborate with the engineering team to delve into the root causes of identified malfunctions by leveraging the information gathered from daily intake reports.
- Conduct comprehensive analyses to support the development and execution of Non-Conformance Events (NCE) and Corrective and Preventive Action (CAPA) strategies.
Quality Assurance Laboratory Intern
Baxter
04.2020 - 10.2020
- Proficient in evaluating reports encompassing sterilization processes, bioburden assessments, endotoxin control measures, and audit findings.
- Actively engaged in environmental monitoring protocols to ensure compliance with industry standards.
- Provided valuable support in preparing specialized service requests pertaining to sterilization procedures.
- Demonstrated expertise in reviewing, documenting, and analyzing reports related to bioburden and dose audits, contributing to quality control and regulatory compliance efforts in the field.
Education
Bachelor's Degree - Chemical Engineering
Universidad Autónoma De Baja California
Tijuana 08.2020
Skills
Responsible
Proactive
Honest
Punctual
Teamwork
Patient
Certification
Lean Six Sigma Yellow Belt
Certification
Lean Six Sigma Green Belt
Certification
Lean Six Sigma Black Belt
Certification
Languages
English
Bilingual or Proficient (C2)
Spanish
Bilingual or Proficient (C2)
French
Intermediate (B1)
Timeline
Supplier Quality Engineer
Medtronic
10.2023 - Current
QA/RA Associate Analyst
Baxter
10.2020 - 10.2023
Quality Assurance Laboratory Intern
Baxter
04.2020 - 10.2020
Bachelor's Degree - Chemical Engineering
Universidad Autónoma De Baja California
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