Software Quality Engineer

Introduction:
Our client is seeking a senior-level Software Quality Engineer to lead compliance initiatives and drive software quality efforts for a critical product launch. The ideal candidate will have a proactive, ownership-driven approach and be able to implement robust procedures aligned with FDA expectations and IEC-62304 standards.

Responsibilities:

• Lead software quality efforts with a proactive, ownership-driven approach.
• Heavy emphasis on general V&V activities.
• Validate tools and spreadsheets to ensure compliance with FDA specifications.
• Debug code and perform unit testing to ensure integrity and safety.
• Collaborate with R&D to establish robust SDLC templates and processes.
• Apply knowledge of software risk and safety requirements.
• Support Red/Blue team methodology.
• Flexibility to work across U.S. and European teams.
• Must be able to take ownership and drive compliance initiatives forward.

Requirements:

• Verification And Validation experience.
• Quality Assurance knowledge.
• Experience with Software Development Methodology.
• Understanding of Regulatory Compliance standards.
• Experience working with FDA specifications and IEC-62304 standards.
• Strong communication and collaboration skills.
• Ability to work independently and take ownership of projects.

Logistics & Hiring Details:

• LOA: 6 months to start, potential for extension.
• Location: Remote (EST or CST preferred).
• Interview Process: 45-minute screen, 2-3 rounds total.
• Start Date: ASAP.
• Priority: High for compliance and launch readiness.