Principle Quality Engineer

DAVRON CV: Candidate 1921424

QUALITY ENGINEER — MEDICAL DEVICES | Class II & III | Supplier & Production Quality

Core Expertise

• Quality engineering for Class II and Class III cardiovascular and implantable medical devices.
• Supplier quality management, supplier remediation, and production quality issue resolution.
• Regulatory compliance with ISO 13485, 21 CFR Part 820, MDR and FDA requirements.
• Leading field actions, CAPA investigations, nonconformance resolution, and internal audits.
• Mentoring and supervising engineering teams with over six years of leadership experience.

Project Background

• Supported NPI and sustaining engineering for a Class III left ventricular assist device program.
• Developed implantable orthopedics systems and surgical instrumentation in R&D environments.
• Managed supplier investigations and corrective actions for catheter, guidewire, and stent production.
• Led cross-functional collaborations with R&D, analytical chemistry, and manufacturing to resolve quality issues.
• Conducted checklist-driven mock audits to prepare teams for regulatory inspections and CAPA readiness.

Key Skills

• ISO 13485 | 21 CFR Part 820 | MDR & FDA regulatory requirements
• Supplier Quality | Supplier Audits | Supplier Corrective Action Plans
• CAPA | Nonconformance Investigations | Root Cause Analysis
• Six Sigma methodologies | GSI project leadership
• NPI & Sustaining Engineering | Production Quality Support
• Internal Audits | Mock Audits | Audit Checklist Development

Why Interview this Candidate?

They bring 11 years of medtech engineering experience, including six years focused on quality across Class II and III devices. Proven ability to lead supplier quality improvements, drive CAPAs and field actions, and prepare teams for regulatory inspections. Their cross-functional leadership and Six Sigma background can reduce production defects and strengthen compliance programs.