Adraxe: Quality Affairs Lead

Company Overview

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. The results from the first clinical epilepsy patients are encouraging and we are at the important stage of hiring key personnel, to accelerate our progress and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy.

The Quality Affairs Lead

This role is critical to ensuring design control rigor, DHF integrity, and regulatory readiness for IDE and eventual PMA, while effectively overseeing external partners and maintaining compliance without slowing execution. The impact is company-wide—de-risking the regulatory pathway, accelerating development timelines, and ensuring product safety and quality—directly supporting Adraxe’s mission to deliver breakthrough, minimally invasive neuromodulation therapies to patients.

Responsibilities

• Own and execute Adraxe’s quality strategy by building and maintaining the QMS
• Lead design controls and DHF integrity
• Embed risk management across product development and clinical activities
• Solve complex challenges around maintaining compliance without slowing execution
• Manage quality across external partners
• Prepare the company for FDA scrutiny and IDE/PMA milestones
• Key initiatives include QMS build-out, IDE readiness, supplier qualification and QMAs, risk management implementation, and inspection readiness, while also establishing scalable post-market systems
• Works cross-functionally with Engineering, Clinical, and Regulatory teams
• Partners closely with leadership
• Oversees external vendors such as CDMOs, design firms, and test labs to ensure consistent quality and regulatory alignment across the program

Requirements

• Core technical or functional competencies:
• Deep expertise in medical device Quality Systems (QMS) and design controls for Class III devices
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
• Hands-on experience with DHF management, traceability, verification & validation
• Supplier quality management, audits, and Quality Management Agreements (QMAs)
• Inspection readiness, CAPA, nonconformance management, and internal auditing
• Familiarity with IDE/PMA requirements and supporting regulatory submissions
• Working knowledge of IEC 60601, IEC 62304, and ISO 10993

Qualifications

• Relevant experience (years, domain, tools, etc.):
• 10+ years in medical device quality or quality/regulatory or Quality Engineering roles
• Direct experience with Class III and implantable devices (ideally neuromodulation)
• Proven track record owning design controls and DHF in product development
• Experience supporting IDE and/or PMA submissions
• Strong background managing external partners (CDMOs, design firms, test labs)
• Experience building or scaling quality systems in early-stage or fast-paced environments
• Prior experience leading or mentoring quality teams

Skills

• Key behaviors aligned with our values:
• Ownership: Takes full accountability for quality outcomes and regulatory readiness
• Grit: Navigates ambiguity and startup constraints while maintaining high standards
• Curiosity: Proactively identifies gaps, asks the right questions, and continuously improves systems
• Sound judgment: Balances compliance with speed; makes risk-based, pragmatic decisions
• Adaptability: Thrives in a fast-evolving environment and adjusts processes as the company scales
• Collaboration: Works effectively across functions and with external partners to drive alignment

Benefits

Not specified

Pay

Not specified

Schedule

Not specified