Quality Technician

Roles and 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

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