Quality Engineer - Lead
VRK IT Vision Inc. · Jacksonville, FL · 4 mo ago
On-siteQuality AssuranceFull-time
Key Responsibilities
- Lead and moderate TRB meetings with cross-functional stakeholders.
- Evaluate design intent, risks, usability, and regulatory implications.
- Drive structured and objective technical and quality discussions.
- Ensure compliance with design control and technical documentation requirements.
- Engage SMEs across technical, engineering, RAQA, and manufacturing teams.
- Communicate assertively, push back, and say no when quality or compliance is at risk.
- Act as the primary bridge between change owners and review teams.
- Evaluate and improve TRB and change management workflows.
- Identify gaps, bottlenecks, and inefficiencies.
- Drive continuous improvement initiatives.
Essential Skills
- Senior Quality Engineer TRB (Technical Review Board) Lead
- EIS: Medical Device & Regulations
- EIS: MDD
- Risk Management