Quality Affairs Lead

Responsibilities

• Build and own a lean, scalable Quality Management System (QMS) to support the transition from clinical success to full commercialization
• Lead design controls and ensure Design History File (DHF) integrity
• Embed risk management processes across product development and clinical activities
• Manage quality across external partners, including CDMOs, design firms, and test labs
• Prepare the company for FDA scrutiny and IDE/PMA milestones
• Oversee supplier qualification, Quality Management Agreements (QMAs), and inspection readiness
• Establish scalable post-market systems and manage CAPA and nonconformance

Requirements

• 10+ years of experience in medical device quality, quality/regulatory, or Quality Engineering roles
• Deep expertise in Quality Systems (QMS) and design controls for Class III implantable devices
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
• Hands-on experience with DHF management, traceability, verification, and validation
• Proven track record supporting IDE and/or PMA submissions
• Experience managing external partners such as CDMOs and design firms
• Working knowledge of IEC 60601, IEC 62304, and ISO 10993

Preferred Qualifications

• Experience building or scaling quality systems in early-stage or fast-paced startup environments
• Prior experience leading or mentoring quality teams

About the Company

Adraxe Corporation is an innovative medical device startup focused on the design, development, and launch of breakthrough, minimally invasive neuromodulation solutions to address unmet patient needs. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy.