Dulce Caedo
San Diego
Summary
11 years of broad engineering experience in the Medical Device Manufacturing industry. Great experience in Quality Control departments. A dynamic, creative, proactive and result driven professional with great sense of getting things done and a lean mentality. Worked on Lean Manufacturing environment, Regulation, Transfer, Stabilization and Validation processes (IQ/OQ/PQ). Active and technically proficient in Six Sigma tools for effectiveness and assurance of Quality Systems. Expert in the compliance of external and internal medical regulations. Well versed in compliance of ISO 13485 and 21 CFR Part 820 - Quality system regulation (QSR/QMS) Part 11, Part 210, 211, 820, 483 remediation, Owner and collaboration to CAPA Investigate and corrective actions.
Overview
11
11
years of professional experience
Work History
Supplier Quality Engineer
Candela Medical
San Diego
11.2022 - 12.2025
- Establish a process to technically assess the capabilities of suppliers in a commodity or product segment.
- CMOs management to ensure complying with quality system.
- Management complaints between customer and CMOs manufacturing process.
- Root causes analysis and investigation follow up with CMO and approval (IQ, OQ and PQ documents).
- Supplier Audit process and follow up Non conformance reports.
- Supplier Corrective Action Request (SCAR) according to Quality Agreements.
Sr. Quality Engineer
Vastek Inc Group
San Diego
12.2021 - 11.2022
- Ensured Design Control and product design/ Assurance documents created, approved, and ready for regulatory and Internal Audits and external audits.
- Facilitated design change orders for many existing products and new product development enhancements to some functional components other duties involved Design of Experiments (DOE), Process Characterization and concept feasibility analysis.
- Ensured compliance with internal and external Audits to quality and regulatory requirements during product development cycle and commercialization of Class II and Class III new products.
- Involved in Risk Management activities (RMP, HA, DFMEA, PFMEA and RMR).
- Authored various Test Method Validations (Gage R and R using Minitab) and performed Root Cause Analysis on various issues pertaining to CAPAs and NCRs.
- Incorporated the core Quality System Record (QSR) types (e.g., Design History File (DHF), Device History Record (DHR), Device Master Record (DMR)).
Project Quality Engineer
Fisher & Paykel Healthcare
Tijuana
04.2020 - 12.2021
- Reviewed and wrote documents for Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation (Gage R&R), Process FMEAs.
- Performed and wrote test method validations and IQ/OQ/PQ Wrote and executed Gauge R&R studies.
- Used FMEA analysis to determine root cause of problems.
- Performs FAI (First Article Inspection) and/or purchased product qualifications per applicable.
- Update of all R&D/Quality documentation (e.g., Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files.
- Led IQ/OQ/PQ and Gage R&R, QA support of ECN, NCR, and Internal & Supplier Audits.
- Improve the transfer process output time in the cutting process from 500 to 700 per day.
- Design Reviews (Design input, Design Output, Design V&V and Design Change).
New Product Introduction Quality Engineer
Jabil Healthcare
Tijuana
04.2019 - 04.2020
- Run test methods validation for process development.
- Collaboration and approval in the development of process for introduction of new products (OQ, PQ, PC, IQ).
- Customer collaboration requirements and compliance.
- Development of Control plan and PFMEA.
- Comply with the regulation in the validation of processes for new products.
New Product Introduction Quality Engineer
Medtronic
Empalme
05.2017 - 04.2019
- Defines, develops, and implements Quality Engineering strategies, which contribute to the campus strategic directions.
- Collaboration and approval in the development of process for introduction of new products (OQ, PQ, PC, IQ).
- Run test methods validation (TMV) for process development.
- Comply with the regulation in the validation of processes for new products.
- Development of Process PFMEA for the process based on DFMEA.
- COS (Cell Operation System) implementing to improve output from 15 ea to 25 ea.
Quality Engineer Manufacturing Area
Medtronic
Empalme
10.2014 - 05.2017
- Quality inspection system and special requirements in the manufacture and final product of medical devices.
- Assurance of the regulation of the quality system, implementing process improvements.
- Monitor Non-conforming product handling.
- Complaints investigations to find root causes (RCA).
- Participating in Kaizen events and generating process improvements.
- Quality system changes for implementing corrective and preventive actions on works instructions.
- Participate in internal and external audit (ISO 13485, FDA).
- First Time Quality (FTQ) Implementation to improve the process and efficiency of Yield from 65% to 85%, continuous Improvement.
- Trending Analysis KPIs (Key Performance Indicator) to improve perform process Scrap rate to defects from 1.8 to 0.5.
Education
Bachelor's degree - Chemical Engineer
TECHNOLOGICAL INSTITUTE OF SONORA
05.2014
Master' s Degree - Business Administration Specializing, Quality and Productivity
TECHNOLOGICAL INSTITUTE OF HIGHER STUDIES OF MONTERREY
01.2022
Skills
- Teamwork
- Great Communication
- Problem Solving (DMAIC)
- Risk Management (PFMEA, HA, DFMEA)
- Statistics (Green Belt Certificate)
- Internal and External Audits
- Validation expertise
- Lead Auditor Certification ISO13485 and ISO 19001
Languages
English
Spanish
Phone - Number
(619) 617-2662
Timeline
Supplier Quality Engineer
Candela Medical
11.2022 - 12.2025
Sr. Quality Engineer
Vastek Inc Group
12.2021 - 11.2022
Project Quality Engineer
Fisher & Paykel Healthcare
04.2020 - 12.2021
New Product Introduction Quality Engineer
Jabil Healthcare
04.2019 - 04.2020
New Product Introduction Quality Engineer
Medtronic
05.2017 - 04.2019
Quality Engineer Manufacturing Area
Medtronic
10.2014 - 05.2017
Bachelor's degree - Chemical Engineer
TECHNOLOGICAL INSTITUTE OF SONORA
Master' s Degree - Business Administration Specializing, Quality and Productivity
TECHNOLOGICAL INSTITUTE OF HIGHER STUDIES OF MONTERREY