Quality Assurance Specialist

About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

A Day In The Life Of Our Quality Assurance Specialist:

• Support the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes in compliance with applicable regulatory and quality system requirements
• Partner with cross-functional teams to facilitate the timely execution of CAPA activities, including investigation support, action tracking, effectiveness verification, and closure readiness
• Support and perform quality investigations, including root cause analysis, data gathering, risk assessment, corrective action development, and Verification of Effectiveness (VOE)
• Coordinate and support CAPA activities by tracking timelines, following up on deliverables, identifying risks to completion, and helping drive records toward timely closure
• Maintain and improve quality system procedures, work instructions, templates, forms, and records to ensure clarity, compliance, and process effectiveness
• Support change control activities, including document revisions, implementation tracking, and cross-functional coordination
• Perform data analysis, trending, and reporting of quality metrics to identify systemic issues, monitor performance, and support continuous improvement initiatives
• Support internal and external audits, and regulatory inspections, including preparation of documentation and follow-up activities
• Support inspection readiness and help ensure quality records are complete, accurate, and audit-ready
• Participate in continuous improvement initiatives to strengthen quality systems, streamline processes, and improve compliance and operational effectiveness
• May include other duties as assigned by Management

About You

• Bachelor's degree in Life Science, Engineering, Quality, or a related technical discipline with 2-5 years of experience in Quality Assurance, Quality Systems, or Quality Engineering within a regulated industry
• Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and applicable quality system requirements, including good documentation practices and risk-based decision making
• Experience with Quality Management System (QMS) processes, including CAPA, investigations, change control, document control, training, and nonconformance management
• Proficiency with eQMS/document control systems (e.g., Arena PLM) and Microsoft Office applications
• Strong analytical, problem-solving, organizational, and communication skills with attention to detail
• Experience with quality metrics, data trending, and reporting preferred
• Self-starter with the ability to manage multiple priorities, work independently, and drive tasks to completion in a fast-paced environment
• Strong written and verbal communication skills with the ability to collaborate effectively across departments and provide coaching on quality system expectations
• Detail-oriented with a commitment to accuracy, compliance, and high-quality documentation

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