Quality Assurance Manager

DAVRON CV: Candidate 1931139

QUALITY LEADER | MEDICAL DEVICE MANUFACTURING | QMS, ISO 13485 & FDA COMPLIANCE

Core Expertise

• Developing and implementing ISO 13485-compliant Quality Management Systems aligned with FDA 21 CFR Part 820.
• Leading regulatory readiness and audit management, serving as Management Representative during FDA and ISO inspections.
• Driving process validation and statistical control through IQ/OQ/PQ protocols and capability analyses (Cpk/Ppk).
• Establishing supplier quality programs across large vendor networks, executing audits, agreements, and corrective actions.
• Applying Lean Six Sigma methodologies to reduce Cost of Quality and improve manufacturing yield.

Project Background

• Architected and deployed a compliant QMS for a new medical device facility, achieving certification within six months.
• Orchestrated 200+ process validations and capability studies to secure robust process control across multiple product lines.
• Reduced customer returns 73% by identifying systemic failure modes and implementing sustainable corrective actions.
• Lowered Cost of Quality 14% through standardized procedures, workforce training, and embedded process controls.
• Directed supplier quality for 150+ vendors, improving on-time delivery and supplier accountability via audits and agreements.

Key Skills

• Quality Systems & Regulatory | ISO 13485 | FDA 21 CFR Part 820 | QMS deployment
• Process Validation | IQ/OQ/PQ | Statistical Process Control (Cpk/Ppk) | Validation Master Plan
• CAPA | Root Cause Analysis | FMEA | Complaint and NCR management
• Supplier Quality Management | Vendor Audits | Quality Agreements | Incoming inspection
• Lean Six Sigma Black Belt | Continuous Improvement | KPI development
• Measurement & Inspection Systems | CMM programming | Lab operations | GMP

Education

• Executive Education, Management Essentials — Harvard Business School
• Certificate, Medical Device Engineering — UCLA
• MBA — Sharif University

Awards & Recognition

• Certified Medical Device Auditor (ASQ)
• Six Sigma Black Belt; Lean Six Sigma Green Belt
• ISO 13485:2016 Lead Auditor

Why Interview this Candidate?

They are a strategic quality leader with 18+ years in medical device manufacturing who rapidly builds and scales compliant QMS while maintaining audit readiness. Proven record includes a 73% reduction in customer returns, 14% Cost of Quality reduction, and leadership of 200+ validations. Offers hands-on audit leadership, supplier control expertise, and Lean Six Sigma-driven continuous improvement to reduce product risk and support operational growth.