About this Candidate
DAVRON CV: Candidate 1928649
QUALITY LEADER | QMS, SUPPLIER QUALITY & MEDICAL DEVICE REGULATORY COMPLIANCE
Core Expertise
- Global QMS leadership across medical devices, electronics, and precision manufacturing
- Supplier quality engineering, audits, ASL/AVL management, and CAPA/SCAR oversight
- Regulatory compliance for ISO 13485/9001 and FDA 21 CFR 820; audit readiness
- Lean Six Sigma-driven process optimization delivering multimillion-dollar cost reductions
- Product lifecycle quality: FAIs, MRB, validation (IQ/OQ/PQ), MDR and post-market surveillance
Project Background
- Led global supplier qualification and audit programs across North America, Europe, and Southeast Asia
- Implemented enterprise QMS consolidation, ISO transitions, and ERP migration to standardize processes
- Directed CAPA investigations, root-cause analyses, and effectiveness verification for complex failures
- Drove supplier second-source and commodity sourcing initiatives achieving $25M annual savings
- Established KPI dashboards, SPC/CPCP, and Six Sigma projects to improve yield and reduce defects
Key Skills
- QMS | ISO 13485 | ISO 9001 | ISO 14001 | ISO 16949
- Supplier Quality | ASL/AVL management | Auditing | Supplier qualifications
- CAPA | 8D | FMEA | PPAP | APQP | IQ/OQ/PQ | Validation
- Lean Six Sigma | DMAIC | Kaizen | TPS | OEE | 5S
- Statistical methods | SPC | GR&R | DOE | Reliability prediction/modeling
- ECO/Document Control | BOM & ASL ownership | SFDC reporting | Budgeting & forecasting
Education
- B.S., Industrial Engineering — San Jose State University
Awards & Recognition
- Certified BSI internal auditor
- Six Sigma Lean certification
- Dale Carnegie Professional Development
Why Interview this Candidate?
Experienced quality leader with deep expertise in QMS, supplier quality, and medical-device regulatory compliance. Proven track record driving multimillion-dollar cost savings, yield improvements, and successful ISO transitions. Strong cross-functional leadership and hands-on problem solving enable immediate impact on manufacturing, supplier performance, and audit readiness.
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