Quality Technician - Neptune Medical

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 for decades to come.

TITLE:  Quality Technician

POSITION SUMMARY: 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).

ROLES AND RESPONSIBILITIES

Manufacturing Quality & Inspection

• 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

Nonconformance & Investigation Support

• 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

Data Collection & Continuous Improvement

• 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

Equipment & Testing

• 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

Documentation & Quality Systems Support

• 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)

Cross-Functional Collaboration

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

 REQUIRED QUALIFICATIONS:

• 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

PREFERRED QUALIFICATIONS:

• 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 (IQ/OQ/PQ)
• Experience supporting audits and regulatory inspections

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station.

Our job titles may span more than one career level. The starting hourly rate for this role is between $35-$40/hour depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.