We're #hiring a new QA Manager in Plano TX. Apply today or share this post with your network.

FoxEyes Corporation — an emerging leader in next-generation AI-guided surgical robotics — is growing rapidly, and we are looking for an experienced Quality Assurance (QA) Manager / Head of Quality to build and lead our Quality Management System (QMS) as we move toward FDA 510(k) submission and global commercialization.

If you are passionate about shaping the future of surgical robotics and building a world-class QMS from the ground up, we’d love to meet you.

Position: QA Manager / Head of Quality

Location: 4351 Mapleshade Ln, Plano, Texas (On-site)

Industry: Medical Devices / Surgical Robotics

Type: Full-time

What You Will Lead

You will be the owner of FoxEyes’ Quality Management System, setting the foundation for compliance with:

ISO 13485:2016

FDA 21 CFR Part 820 (QSR)

ISO 14971:2019 (Risk Management)

IEC 62304 (Medical Software Lifecycle)

IEC 60601 (Electrical Safety)

ISO 15223 / ISO 20417 (Labeling & Symbols)

FDA Part 11 (Electronic Records)

This role will partner directly with engineering, robotics, clinical, and manufacturing teams to ensure our dual-robot spine surgery system meets the highest standards of safety, quality, and performance.

Key Responsibilities

Establish, maintain, and continuously improve our ISO 13485-compliant QMS

Lead design controls, verification/validation, and DHF/DMR/DHR management

Implement risk management processes (FMEA, hazard analysis)

Manage supplier quality, audits, and incoming inspection processes

Lead CAPA, complaint handling, and post-market surveillance programs

Coordinate FDA 510(k) quality requirements and support regulatory filings

Prepare the organization for ISO audits and FDA inspections

Oversee sterilization validation, packaging validation, and biocompatibility testing

Train and mentor engineering team members on QMS procedures

What We’re Looking For

7–10+ years of quality experience in medical devices

Proven background working with ISO 13485 and FDA 21 CFR 820

Experience with design controls, CAPA, supplier quality, and internal audits

Strong understanding of ISO 14971, IEC 62304, and IEC 60601

Experience with Class II or Class III devices, ideally robotics or orthopedics

Hands-on experience preparing for FDA 510(k) and ISO audits

Ability to collaborate with software, mechanical, electrical engineers — and surgeons

Startup mindset: proactive, solution-driven, and ready to build from scratch

📨 How to Apply

If you're excited to build a next-generation QMS and be a core part of FoxEyes' journey, please send your resume to:

info@foxrbt.com

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