About this Candidate
DAVRON CV: Candidate 3810602
QUALITY ENGINEER | REGULATED MANUFACTURING | AUDITS, SPC, CAPA, DESIGN CONTROL
Core Expertise
- Quality systems management across cGMP, ISO 13485, IATF 16949, and ISO 9001 environments.
- Root-cause investigations, CAPA, deviation closure, and corrective action implementation.
- Design control and verification for combination products under FDA and ISO requirements.
- Statistical process control, control plans, PFMEA, and APQP/PPAP for production readiness.
- Supplier qualification, audits, SRM risk assessments, and nonconformance disposition.
Project Background
- Led failure investigations and forensic analysis on mechanical and electromechanical components.
- Executed GMP lifecycle activities including EBR review, validations, change control, and CAPA.
- Implemented SPC and automated deviation detection, reducing semiconductor scrap rates by 15%.
- Developed control plans that increased first-pass yield by 10% for production lines.
- Supported design control activities and ISO/FDA compliance for combination product development.
Key Skills
- MES | Veeva | Salesforce | Smartsheet | SAP | Agile PLM | BioConnect | BioVia
- Statistical Process Control | Control Plans | PFMEA | APQP/PPAP implementation
- GMP | cGMP | FDA 21 CFR Part 820 | ISO 13485 | IATF 16949 | ISO 9001
- Root Cause Analysis | 8D | 5 Whys | Ishikawa | CAPA implementation and closure
- Dimensional inspection | GD&T | FARO Arm CMM | FAI | in-process and final inspection
Education
- B.S., Industrial Engineering — Universidad de Estudios Avanzados
Awards & Recognition
- IATF 16949:2016 certified — automotive quality systems and supplier processes
- ISO 14001 certified — environmental management systems and compliance improvement
- Lean Manufacturing Yellow Belt — process improvement and waste reduction training
Why Interview this Candidate?
A versatile quality engineer with ~8 years of regulated-industry experience across pharmaceuticals, medical devices, semiconductors, and automotive. Delivered measurable results including a 10% increase in first-pass yield and a 15% reduction in scrap through control plans and SPC automation. Strong competence in GMP/ISO compliance, design control, root-cause investigations, and supplier quality makes them ready to drive immediate improvements.
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