Quality Lead

Responsibilities

• Own and continuously improve the quality management system (QMS)
• Partner with Engineering, Clinical, Manufacturing, and Regulatory to define and rightsize procedures
• Drive automation and tooling improvements for QMS processes
• Conduct and facilitate internal and external audits
• Build and maintain a high-quality supplier base and manage quality agreements
• Represent the company in audits and inspections with the FDA and standards bodies
• Facilitate core quality processes including NCR/CAPA, risk management, and document review
• Oversee quality-managed training across the organization
• Define and manage the quality team, including performance and career paths

Requirements

• 10+ years of quality experience in the medical device industry
• Progressive leadership responsibility with direct ownership of an ISO 13485 QMS
• Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
• Experience with design controls applied to Class II or Class III devices
• Proven track record of managing quality teams and cross-functional partnerships
• Ability to work onsite full-time in Houston, Texas

Preferred Qualifications

• Experience in early-stage companies scaling quality systems during clinical phases
• Leadership experience taking a product through IDE and into clinical studies
• Experience supporting supplier quality for contract manufacturers of electromechanical or implantable subassemblies
• Familiarity with IEC 62304 or sterile packaging quality requirements

About the Company

Motif is a medical device startup based in Houston, Texas, designing minimally invasive electronic solutions for serious mental health conditions. Using patent-pending wireless power and data transmission, Motif aims to create the smallest implantable brain stimulator to treat mental health disorders.