Quality Technician

Neptune Medical•Burlingame, CA

13d•Onsite

About The Position

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).

Requirements

High school diploma or equivalent required
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 Haves

Associate degree or technical certification preferred
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

Responsibilities

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 escalate issues as appropriate
Support training of production personnel on quality requirements and procedures