Quality Technician

Responsibilities

• Perform incoming, in-process, and final inspections of components and medical devices
• Document inspection and test results in device history records (DHRs)
• Identify, document, and segregate nonconforming materials
• Assist in root cause investigations and CAPA processes
• Collect and analyze in-process quality data to support process monitoring
• Operate, maintain, and calibrate inspection equipment such as calipers and microscopes
• Review quality documentation for completeness and accuracy in compliance with GDP and GMP
• Collaborate with Manufacturing and Engineering teams to resolve quality issues

Requirements

• High school diploma or equivalent
• 3–5+ years of experience in Quality Assurance/Quality Control in manufacturing
• Working knowledge of FDA 21 CFR Part 820 and/or ISO 13485
• Experience with inspection methods, sampling plans, and interpreting engineering drawings
• 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
• Hands-on experience with dimensional and visual inspection equipment
• Understanding of validation activities (IQ/OQ/PQ)
• Experience supporting audits and regulatory inspections

About the Company

Neptune Medical is an innovative, venture capital funded medical device startup building a fully flexible medical robot that enables doctors to reach deep into human anatomy.