Manager, Quality Assurance

Triple Ring Technologies, Inc. offers a unique environment for talented individuals interested in undertaking varied technical challenges, primarily in medical device and life science industries. Headquartered in Newark, CA, we are an innovative research and development company that partners with clients to deliver complex technical solutions. Our highly interdisciplinary team includes senior professionals from industry, finance, and academia, with extensive experience in medical device, life science, clean tech, security, and industrial technologies. We rely upon each other for technical excellence, real-world engineering and commercial wisdom. Learn more at www.tripleringtech.com . Job Summary The Manager of Quality Assurance will maintain and lead the implementation of Triple Ring’s Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development of hardware, software, and AI/ML-enabled systems, engineering builds, clinical builds, and transfer to manufacturing. Responsibilities • Provide project teams with the guidance necessary to maintain a high level of ISO13485:2016 QMS compliance, with specific focus on hardware, software and system design assurance activities. • Ensure that medical device design project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed • Ensure that medical device design project quality activities are efficient and effective and performed in a proactive manner • Oversee the generation and maintenance of quality records that are consistent with Triple Ring’s QMS • Ensure that quality records are maintained in a state of readiness for external audits and regulatory inspections • Maintain and regularly update Triple Ring’s library of applicable technical, quality, and risk management standards • Maintain Triple Ring’s ISO13485:2016 certification, including managing and conducting internal audits • Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to ISO13485:2016 quality management systems • Support and manage ISO13485:2016QMS related training and professional development for Triple Ring scientific and technical staff • Own the Management Review process, managing and reporting project and operational quality metrics to management • Provide input to quality-related planning to meet short and long term business goals • Provide management with objective evaluation of overall quality performance and guidance for implementation of improvements • Actively participate in developing and deploying effective continuous improvement of Triple Ring’s quality management processes • Serve as the ISO13485:2016 QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary • Manage Triple Ring’s Document Control function and related personnel Education, Experience, and Skills • Expert in medical device design assurance activities, including design controls, risk management, software development lifecycle, design reviews, design transfer and medical device regulatory submissions. • Demonstrated hands-on experience personally executing and reviewing design assurance deliverables—design controls, Design History File (DHF) and requirements traceability, risk management, and verification and validation (V&V)—for hardware, software, and AI/ML-enabled medical devices; this is a hands-on technical role, not an oversight- or audit-only function. • Mini