Neptune Medical

Neptune Medical

Senior Quality System Specialist (Temporary)

Burlingame, California, United States · Senior · Contract

Sponsorship not specifiedDetected 48 days ago
ComplianceProduct ManagementExcelControlsFDA RegulatoryMedical DevicesCommunicationMicrosoft Office

About the role

  • 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 equipment control, including preventive maintenance schedules, equipment ID assignment, and equipment history file maintenance.
  • Ensure training plans are established for Neptune Medical employees.

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.
  • Oversee Complaints Handling system. Lead monthly complaint meeting.
  • Provide Management Review input. Own approval of Management Review output.
  • Manage post market surveillance activities in the applicable jurisdictions (USA & EU). Author applicable reports.
  • Coordinate and maintain calibration programs for inspection, measurement, and test equipment, ensuring timely calibration and proper documentation.
  • Develop, deliver, and track quality system training for staff to ensure understanding and adherence to QMS requirements.

Requirements

  • Bachelor's degree in Science, Engineering, or a related field.
  • 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.
  • Participate in Process Nonconformance (PNRs) and Material Nonconformance (MRRs) review, as required.
  • Own CAPAs, as required.

Nice to have

  • Experience using an electronic quality management system, e.g., Arena, EtQ.
  • Experience using Propel is preferred.

Compensation

  • Manage the Neptune Medical Approved Supplier List, including annual review.
  • 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.

Company info

  • 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.
  • Senior Quality System Specialist (Temporary)
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This listing is sourced directly from Neptune Medical's careers page and normalized into a canonical job model.