Motif Neurotech - Quality Lead

• 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 • Build and maintain a high-quality supplier base • 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 Motif elects to follow • 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 • Serve as the internal culture carrier for quality — a systems thinker who helps the team build quality in rather than inspect defects out • 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 • This is not an exhaustive list of duties and you may be asked to perform different tasks if your role within or the objectives of the organization changes. • 10+ years of quality experience in the medical device industry with progressive leadership responsibility, including direct ownership of an ISO 13485 quality management system • To be 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