Senior Quality System Specialist

Neptune Medical•Burlingame, CA

13h•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Science, Engineering, or a related field.
Minimum 5 years of experience in quality assurance or quality systems within the medical device industry, with 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.
Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software.
Be results-oriented with appropriate urgency.
Good organizational, oral and written communication skills.
Willingness to work in a startup environment and adapt to changing needs and priorities.
Eagerness to learn new things.

Nice To Haves

Experience using Propel is preferred.

Responsibilities

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.
Provide training and feedback to change order initiators and approvers.
Generate reports on status of change orders.
Maintain and update the standards library and quality records
Support licensing and regulatory submissions as needed.
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 ID assignment, 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 internal and external quality audits.
Perform analysis for Quality metrics, Management Review, etc.
Work in accordance with quality system procedures.