Senior Quality System Specialist

About the Company

Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Our team is currently building a fully flexible medical robot designed to disrupt flexible endoscopy.

Responsibilities

• Oversee and maintain document control systems including SOPs, Device/Batch Records, and Design & Development Files
• Support quality system processes including CAPA management and continuous improvement initiatives
• Oversee the Complaints Handling system and lead monthly complaint meetings
• Manage the Approved Supplier List and perform annual reviews
• Manage post market surveillance activities for USA and EU jurisdictions
• Coordinate calibration programs and oversee equipment control and preventive maintenance
• Develop, deliver, and track quality system training for staff
• Plan, conduct, and support internal and external audits to ensure compliance with FDA QMSR, ISO 13485, and EU MDR
• Perform analysis for Quality metrics and Management Review

Requirements

• Bachelor’s degree in Science, Engineering, or a related field
• Minimum 7 years of experience in quality assurance or quality systems within the medical device industry
• Hands-on experience in document control, equipment management, and audits
• Experience using an electronic quality management system (e.g., Arena, EtQ)
• Understanding of 21 CFR 820 and ISO 13485 quality system requirements
• Proficiency in MS Office Suite and PDF software
• Ability to work in a fast-paced startup environment

Preferred Qualifications

• Experience using Propel eQMS