Quality Lead

Motif Neurotech•Houston, TX

3d•Onsite

About The Position

Motif is a medical device startup based in Houston, Texas, designing and developing minimally invasive electronic solutions for serious mental health conditions. They are seeking a hands-on quality leader to own and improve the quality management system for a first-in-class implantable neurostimulator. This role involves partnering with engineering, clinical, regulatory, and manufacturing to ensure high-quality products for patients. The ideal candidate will shape the QMS, supplier quality, and risk infrastructure of a venture-backed Class III medical device company moving through its clinical phase.

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
Authorized to work in the United States

Nice To Haves

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

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
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