Santiago Pache
Industrial Engineer
Santa Ana,CA
Summary
ISO 13485 Lead Auditor and Industrial Engineer with 10+ years in supplier quality and manufacturing engineering. Expertise in process validation (IQ, OQ, PQ, TMV), supplier qualification (PPAP, CQRs, FAIR), and root cause analysis (RCCA, SCAR). High school electronics foundation in circuits, microcontrollers, and PCB principles supports transition to aerospace electronics. Achieved 20% defect reduction and $100K cost savings via supplier optimization. Ready for AS9100-compliant roles, ensuring on-time delivery and reliability.
Overview
12
12
years of professional experience
2
2
Certifications
2
2
Languages
Work History
Senior Supplier Quality Engineer
IRhythm Technologies Inc.
11.2024 - Current
- Lead commodity-related quality control, resolving functional issues in PCB/PCBA components, reducing defect rates by 8% through targeted supplier interventions.
- Conduct ISO 13485-compliant supplier audits, applying electronics knowledge to validate processes, with skills transferable to AS9100 standards.
- Establish ongoing supplier site evaluation parameters, maintaining long-term quality control standards for 15+ suppliers.
- Manage PPAP approvals, achieving 97% on-time compliance for PCBAs
- Travel to supplier facilities to verify staff qualifications via inspections and investigations, ensuring compliance with quality requirements.
Senior Supplier Quality Engineer
New World Medical
03.2023 - 09.2024
- Lead PPAP approvals for 20+ suppliers, achieving 98% on-time compliance for components
- Conduct supplier audits and recertification, ensuring ISO 13485 compliance, with transferable skills to AS9100 standards.
- Provide manufacturability feedback to design teams for medical device sub-assemblies, reducing defect rates by 10% through supplier process optimization.
- Maintained amiable relationships with suppliers through difficult quality control issues, supporting healthy business interactions.
Project Manufacturing Engineer II
Medtronic
04.2019 - 04.2021
- Managed process validations (IQ, OQ, PQ, TMV) for product transfers, achieving 100% protocol approval and sustaining quality
- Reduced scrap by 15% and cycle time by 10% through manufacturing line improvements
- Reviewed CAPA and NCMR, ensuring defect mitigation aligned with regulatory standards
- Led transfer of product families from USA to DR, coordinating with suppliers to meet quality and delivery timelines.
Quality Engineer
Oscor Caribe, LLC
05.2018 - 05.2019
- Validated test methods (TMV) for components, achieving 100% compliance
- Reduced scrap by 14.5% through supplier collaboration and process improvements
- Managed SCAR processes, resolving 20+ non-conformances and enhancing supplier performance metrics.
Project Engineering Technician
Edwards Lifesciences
07.2015 - 05.2018
- Supported NPI by validating design changes (PQ, OQ, IQ), launching 3 product lines on time
- Achieved $100K cost reduction and 20% scrap reduction through process optimization, applicable to high-volume electronics.
- Contributed to FMEA for components, leveraging electronics knowledge to ensure quality.
Senior Supplier Quality Engineer
Iziel Healthcare
01.2014 - 07.2015
- Approved CQRs for 15+ suppliers, focusing on precision components, reducing non-conformances by 12% via RCCA and SCAR processes.
- Collaborated with engineering to develop supplier processes for complex assemblies, applying validation protocols adaptable to PCB/PCBA production.
- Trained teams on quality standards, enhancing supplier reliability for high-volume manufacturing.
Education
Bachelor of Science - Industrial Engineering
APEC University
Santo Domingo, Dominican Republic 01.2013 - 10.2017
High School Diploma, Electronics Focus - Component Functionality And Basic PCB Design
Salesian Technical Institute
Santo Domingo, Dominican Republic 08.2008 - 10.2012
Skills
Technical Skills: Supplier Quality (PPAP, CQRs, FAIR), Process Validation (IQ, OQ, PQ, TMV), FMEA, APQP, GD&T, CAPA/SCAR/NCMR, RCCA, ISO 13485, AS9100 (Training Planned)
Electronics Skills: Knowledge of PCB/PCBA processes, microcontrollers, sensors, connectors; familiar with IPC-A-610, PC-J-STD-001 (self-study); adaptable to oscilloscopes, logic analyzers
Software Tools: MS Office (Excel, Project, Word, Visio – Advanced), Minitab (Intermediate), Jira (Basic), Altium/Eagle (Basic)
Certification
Certified ISO 13485 Lead Auditor, Oriel STAT A MATRIX (Credential ID 202768)
Timeline
Senior Supplier Quality Engineer
IRhythm Technologies Inc.
11.2024 - Current
Senior Supplier Quality Engineer
New World Medical
03.2023 - 09.2024
Project Manufacturing Engineer II
Medtronic
04.2019 - 04.2021
Quality Engineer
Oscor Caribe, LLC
05.2018 - 05.2019
Project Engineering Technician
Edwards Lifesciences
07.2015 - 05.2018
Senior Supplier Quality Engineer
Iziel Healthcare
01.2014 - 07.2015
Bachelor of Science - Industrial Engineering
APEC University
01.2013 - 10.2017
High School Diploma, Electronics Focus - Component Functionality And Basic PCB Design
Salesian Technical Institute
08.2008 - 10.2012