Quality Assurance Manager

Company Description

Triple Ring 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

• Provide project teams with the guidance necessary to maintain a high level of ISO
  13485:2016 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 ISO
  13485:2016 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 ISO
  13485:2016 quality management systems
• Support and manage ISO
  13485:2016
  
  QMS 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 ISO
  13485:2016 QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary
• Manage Triple Ring’s Document Control function and related personnel

• 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.
• Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred
• ISO 13485 - Lead Assessor Certification required. Other ASQ and RAPS Certifications are a plus (e.g., Certfifed Quality Auditor, Certified Quality Engineer, Certified Quality Manager-Operational Excellence)
• Experience hosting external audits and regulatory inspection as primary audit guide a must.
• Strong understanding and application of the following medical device standards is required.
• ISO 13485:2016,
• ISO
  14971:2019,
• ISO/IEC
  62304:2006,
• IEC
  60601-1/IEC
  61010
• In-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy related to medical device development lifecycle, from ideation to commercial distribution.
• Previous experience collaborating with medical device submission, such as US FDA 510(K) and PMA is required.
• Demonstrated knowledge of interpretation and application of 21
  
  CFR
  820 QMSR. Understanding of EU-MDR and…