Analy Quiñonez
Summary
Effective quality professional bringing proven success in driving continuous improvement initiatives in Quality Engineer roles following GMP's, ISO 13485 and CFR820 requirements. Focused and diligent with commitment to fostering corporate mission. Consistently acknowledged for implementing actionable projects to reduce risks and optimize company processes.
Overview
11
11
years of professional experience
Work History
Principal Quality Engineer
Medtronic Mexico
12.2023 - Current
- Developed the MMX Strategy for ANSI/AAMI ST72 compliance following best practice sharing
- Currently leading the execution for ST72 remediation, constantly reporting to external/internal stakeholders, budget development and expense tracking, and resource allocation
- Effectively spearheaded projects for NCMR reduction, resulting in a 50% reduction
- Provide oversight for the development and maintenance of Neuroscience sterilization, microbiology and CEA quality metrics
- Managed Biocompatibility investigation A3 project and CAPA, delivering comprehensive reports to internal and external stakeholders
- Actively engaged collaboration with SMEs
- Collaborated in AOP development and organizational structure for Neurovascular
- Daily basis collaboration with multiple OUs to assure internal requirements compliance
- Oversaw SAP post-sterile inspection plans remediation for Neuroscience.
Sr. Quality Engineer
Medtronic Mexico
09.2020 - 12.2022
- Lead Axium BET Pool testing savings project which saved $137K USD/ year
- Audit response to DEKRA finding initially classified as Major and reduced to Minor after my intervention
- CEA 9 Validation responsible, developing a successful critical strategy for business continuity
- Developed Neurosurgery loads reconfiguration process and established controls for risk reduction
- CAPA BET Missing sampling owner for Neurosurgery
- Detected Marksman BET incorrect specification flow-downed from Design Site and investigation and action plan team member, implementing controls in MMX to prevent recurrence
NPI Quality Engineer
Medtronic Mexico, Manpower
10.2019 - 09.2020
- Sterilization Validation & Loads Setup for Phenom Catheter in a new sterilizer
- TM development and TMV execution for New Product Introduction
- Identified a new failure mode which led to a design change, avoiding post launch field complaints
- Barcode implementation to critical packaging components for Phenom Catheter prior to commercial launch
- Increased units packaged per pallet from 1728 to 1944 (216 units more), this meant a profit of $194,400 USD per sterilization cycle
- Introduction of a new product to the secondary packaging area without affecting the stability of the other products
Research Assistant and Engineering Teacher
Autonomous University of Baja California, UABC
01.2013 - 01.2019
- Statistical parametric and non-parametric data handling, and trend analysis
- Responsible of the evaluation of heavy metals and hydrocarbons from multiple sources in Tijuana, Mexicali and Rosarito
- Laboratory equipment and methods validation
- Multiple Peer-reviewed papers published in International Scientific Journals
- Proficient managing large groups of up to 50 students
- Collaborated in new study plans development for engineering careers successfully approved by Mexican government
- Consecutively evaluated as excellent in teaching skills.
- Educated students on advanced aspects of Chemical Engineering to help each prepare for career in discipline.
Education
PROJECT MANAGEMENT DIPLOMA -
Cetys University
2022
CHEMICAL SCIENCES PHD -
Autonomous University of Baja California
2019
MASTER OF SCIENCE -
Autonomous University of Baja California
2015
CHEMICAL ENGINEER BSc -
Autonomous University of Baja California
2012
Skills
- Excellent attention to detail
- Leadership
- Negotiation
- Fast learner
- Communication
- Critical Thinking
- Planning
- Risk Management
- Problem-solving
- Software: MS Project, Microsoft Office, Minitab, Agile MAP, SAP, Daisy
Accomplishments
- Project Management by Axis Institute
- ISO 13485:2016 Lead auditor by BSI
- Biocompatibility of Medical Devices certification by NAMSA
- Process Validation for Medical Devices by Lean Sigma Academy
- Microbiological Control for Medical Devices according to Applicable Standards by Merck
- Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility by Nelson Labs
- Sterilization of medical devices by Lean Sigma Academy
- Clean room validation by Axis Institute
- First Time Quality (FTQ) coach level 1
- Leadership and Emotional Intelligence by Axis Institute
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Principal Quality Engineer
Medtronic Mexico
12.2023 - Current
Sr. Quality Engineer
Medtronic Mexico
09.2020 - 12.2022
NPI Quality Engineer
Medtronic Mexico, Manpower
10.2019 - 09.2020
Research Assistant and Engineering Teacher
Autonomous University of Baja California, UABC
01.2013 - 01.2019
PROJECT MANAGEMENT DIPLOMA -
Cetys University
CHEMICAL SCIENCES PHD -
Autonomous University of Baja California
MASTER OF SCIENCE -
Autonomous University of Baja California
CHEMICAL ENGINEER BSc -
Autonomous University of Baja California
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