Adraxe: Quality Affairs Lead

adraxe
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 Role

The Quality Affairs Lead exists to build and own a lean, scalable Quality Management System that enables Adraxe to transition from early clinical success into full product development and commercialization of its Class III implantable neurostimulation system. 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. Success in the first 6-12 months looks like establishing a phase-appropriate QMS, achieving audit-ready design controls and risk management processes, supporting a strong IDE submission, and building the foundation for scalable quality operations and team growth.

What You'll Do

In this role, you will own and execute Adraxe's quality strategy by building and maintaining the QMS, leading design controls and DHF integrity, and embedding risk management across product development and clinical activities. They will solve complex challenges around maintaining compliance without slowing execution, managing quality across external partners, and preparing 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. This role works cross-functionally with Engineering, Clinical, and Regulatory teams, partners closely with leadership, and oversees external vendors such as CDMOs, design firms, and test labs to ensure consistent quality and regulatory alignment across the program.

What You Bring
Minimum Qualifications

• 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
• 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

Preferred Qualifications

• Prior experience leading or mentoring quality teams:
• 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