Quality Lead

About the role

We are seeking a hands-on quality leader to own and improve the quality management system that enables a first-in-class implantable neurostimulator to reach patients. This role involves working with our COO and partnering with nearly all other functions in the organization to lead Motif's quality function from early clinical builds through pivotal trials and beyond.

Job Location

Onsite in Houston, Texas

Responsibilities

• Own and continuously improve Motif's quality management system
• Partner with Engineering, Clinical, Manufacturing, and Regulatory to define new procedures as the business evolves, and rightsize existing ones to reduce risk and friction
• Drive automation and tooling improvements that streamline the interfaces between QMS processes and the systems people use day to day
• Conduct and facilitate internal and external audits to ensure the quality system is functioning as designed
• Evaluate suppliers per Motif's supplier management procedure and ensure quality agreements are in place with all necessary parties
• Represent Motif in audits and inspections with FDA and standards bodies (ISO 13485 and others)
• Ensure the quality system meets ISO 13485 and other standards
• Partner with Regulatory to ensure quality processes facilitate compliance with regulatory requirements and adopted standards
• Partner with Engineering to ensure Design History File integrity, and with Clinical to ensure procedures support compliant study execution
• Facilitate the core quality processes — NCR/CAPA disposition, risk management, document review and approval, and Device History Record / Lot Release sign-off
• Oversee quality-managed training across the organization
• Maintain the system of record for training and partner with functional managers to define team-level training needs and monitor compliance
• Build and maintain a high-quality supplier base
• Work with the leadership team and provide quality input into product, clinical, and regulatory decisions
• Define a quality team sufficient to meet the organization's goals, set expectations, manage performance, and create career paths that align individual interests with company objectives

Requirements

• 10+ years of quality experience in the medical device industry with progressive leadership responsibility, including direct ownership of an ISO 13485 quality management system
• Available to work onsite full-time in our Houston, Texas office
• Working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 risk management, and design controls applied to Class II or Class III devices
• Experience directly managing quality teams and a track record of partnering effectively with engineering, manufacturing, clinical, and regulatory functions

Qualifications

• Experience in early stage companies and scaling a quality system in conjunction with organization growth and clinical phases
• Quality leadership experience at a startup or first-of-kind device company taking a product through IDE and into clinical study
• Experience supporting supplier quality for contract manufacturers building electromechanical or implantable subassemblies
• Familiarity with software-of-medical-device standards (IEC 62304) and combination product or sterile packaging quality requirements