Quality Technician

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. 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 fordecades to come.

Quality Technician

The Quality Technician will support manufacturing operations by ensuring in-process and finished medical devices meet established quality requirements, specifications, and regulatory standards. This role is responsible for identifying and documenting quality issues on the production floor, supporting investigations and root cause analysis, managing nonconforming materials, and collecting process and product data to drive continuous improvement.

The technician works closely with Manufacturing, Quality Engineering, and cross-functional teams to ensure rapid response to quality concerns and compliance with applicable quality system regulations (e.g., FDA 21 CFR Part 820, ISO 13485).

• Perform incoming, in-process, and final inspections of components, subassemblies, and medical devices in accordance with approved procedures, drawings, and sampling plans
• Ensure product compliance with specifications, GMP, and regulatory requirements
• Accurately document inspection and test results in device history records (DHRs) and other quality records
• Maintain traceability of materials and finished goods throughout production

• Identify, document, and segregate nonconforming materials
• Support containment activities, including line clearance, product holds, and sorting/rework activities
• Assist in root cause investigations and corrective and preventive actions (CAPA)
• Collaborate with Quality Engineers to analyze trends and recurring issues

• Collect and analyze in-process quality data to support process monitoring and improvement initiatives
• Provide input on quality metrics, yield trends, and defect data
• Partner with Manufacturing and Engineering teams to implement process improvements and error-proofing solutions

• Operate, maintain, and calibrate inspection and test equipment (e.g., calipers, microscopes, gauges)
• Support equipment calibration and environmental monitoring programs as needed
• Perform basic product or material testing in accordance with validated methods

• Review Device History Records (DHRs) and other quality documentation for completeness and accuracy
• Maintain quality records in compliance with document control procedures and regulatory requirements
• Support audits (internal/external) by providing documentation and participating in audit activities
• Ensure adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)

• Work closely with Production, Manufacturing Engineering, and Quality Engineering to ensure timely resolution of quality issues
• Communicate quality concerns clearly and elevate issues as appropriate
• Support training of production personnel on quality requirements and procedures

• High school diploma or equivalent required;
  Associate degree or technical certification preferred
• 3–5+ years of experience in Quality Assurance/Quality Control in a manufacturing environment (medical device industry strongly preferred)
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820) and/or ISO 13485
• Experience with inspection methods, sampling plans, and interpreting engineering drawings and specifications
• Proficiency in Microsoft Office and electronic quality management systems

• Experience in a regulated medical device or life sciences environment
• Familiarity with nonconformance systems, CAPA, and root cause analysis tools (e.g., 5 Whys, Fishbone)
• Hands‑on experience with dimensional and visual inspection equipment
• Understanding of validation activities…