About this Candidate
DAVRON CV: Candidate 1926330
VALIDATION QUALITY ENGINEER | MEDICAL DEVICE | DQ/IQ/OQ/PQ & CSV
Core Expertise
- End-to-end equipment and process qualification (DQ/IQ/OQ/PQ) for medical device manufacturing.
- Risk-based computer system validation and requirement traceability aligned to GAMP 5.
- Quality systems management including CAPA, change control, deviations, and supplier quality.
- Regulatory compliance expertise with FDA 21 CFR Part 820/11, ISO 13485, ISO 14971, and EU MDR.
- Audit readiness and inspection support for FDA and notified body assessments.
Project Background
- Led validation for manufacturing equipment and processes supporting new product introductions.
- Directed computerized system validation for LIMS, SDMS, and adverse event reporting systems.
- Standardized validation frameworks and VMPs, reducing protocol development time by 15–20%.
- Executed supplier audits and implemented CAPAs that reduced recurring supplier defects.
- Managed change control lifecycle and maintained audit-ready documentation in PLM and ERP systems.
Key Skills
- DQ/IQ/OQ/PQ | Validation Master Plans | Protocols & Reports
- CSV | GAMP 5 | FDA 21 CFR Part 11 | RTM & audit trail review
- Risk-based validation | PFMEA | DFMEA | ISO 14971
- CAPA | Deviation Management | 8D & root cause analysis (5-Why, Fishbone)
- TrackWise | Windchill | SAP | Documentum | LIMS
- Statistical sampling (ANSI/ASQ Z1.4), GR&R, and Six Sigma Green Belt process improvement
- SOP development | Training | Validation status tracking & change control
Education
- M.S., Information Technology & Management
- B.E., Engineering
Why Interview this Candidate?
They bring 6+ years validating equipment, processes, and computerized systems within FDA-regulated medical device environments while maintaining audit-ready documentation. Results include standardizing VMPs to cut protocol development time by 15–20% and driving CAPAs that reduced recurring supplier defects. Cross-functional leadership combined with expertise in CSV, PLM/ERP systems, and quality systems enables immediate contribution to validation and compliance programs.
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