Senior Quality System Specialist; Temporary

Senior Quality System Specialist (Temporary)

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. Pathfinder® is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy.

Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

The Senior Quality System Specialist ensures the integrity and compliance of the Quality Management System (QMS) for medical devices, with a focus on document control, calibration, equipment control, audits, and training. This role supports regulatory compliance (FDA, ISO 13485, EU MDR), drives continuous improvement, and collaborates with cross‑functional teams to maintain high‑quality standards throughout the product lifecycle. This position plays a critical role in managing and overseeing the document control processes and systems, ensuring that all documents are properly controlled, maintained, and accessible to authorized personnel.

The ideal candidate will act with passion and intensity in a medical device start‑up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career‑defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

• Oversee and maintain document control systems, ensuring all quality and regulatory documents (SOPs, Device/Batch Records, MDFs, Design & Development Files, change orders) are current, accurate, and compliant with industry standards (FDA QMSR, ISO 13485, EU MDR).
• Support and improve quality system processes, including CAPA management, data integrity, and continuous improvement initiatives (e.g. QMSR Gap Assessment).
• Oversee and improve document control procedures, including revision/version control, document tracking, and secure archiving.
• Oversee Complaints Handling system. Lead monthly complaint meeting.
• Manage the Neptune Medical Approved Supplier List, including annual review.
• Provide Management Review input. Own approval of Management Review output.
• Participate in Process Nonconformance (PNRs) and Material Nonconformance (MRRs) review, as required.
• Own CAPAs, as required.
• Manage post market surveillance activities in the applicable jurisdictions (USA & EU). Author applicable reports.
• Incorporate new and updated external documents (e.g. regulations, standards, guidance) into the Neptune Medical QMS. Perform an annual audit of the External Documents List.
• Coordinate and maintain calibration programs for inspection, measurement, and test equipment, ensuring timely calibration and proper documentation.
• Oversee equipment control, including preventive maintenance schedules, equipment , and equipment history file maintenance.
• Develop, deliver, and track quality system training for staff to ensure understanding and adherence to QMS requirements.
• Ensure training plans are established for Neptune Medical employees.
• Update/assign training plans in eQMS.
• Train new hires on eQMS software and training program.
• Plan, conduct, and support internal and external audits; coordinate audit responses and corrective actions to ensure ongoing compliance with regulatory standards (FDA QMSR, ISO 13485, EU MDR)
• Interact with regulatory bodies and auditors during inspections, providing documentation and ensuring readiness for audits.
• Represent areas of responsibility in the front room of both internal and external quality audits.
• Perform analysis for Quality metrics, Management Review, etc.
• Work in accordance with quality system procedures.

• Bachelor’s degree in Science, Engineering, or a related field.
• Minimum 7 years of experience in quality assurance or quality…