Quality Technician
- Compensation
- $35–$40 / hr
- Location
- Burlingame, California, United States
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Manufacturing
- Posted
Skills
Must have
- 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
Nice to have
- 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
Full description
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 TechnicianPOSITION 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 RESPONSIBILITIESManufacturing 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