Senior Quality System Specialist (Temporary)

Roles and 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.
• 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 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 the front room of both internal and external quality audits.

Required Qualifications

• 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, with hands-on experience in document control, equipment management, and audits.
• Experience using an electronic quality management system, e.g., Arena, EtQ. Experience using Propel is preferred.
• 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.
• 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.