Quality Technician III

Under minimal supervision, the Quality Technician III functions as a senior technical and strategic contributor within the Quality organization. This role is responsible for advanced inspection, calibration, risk management, and quality system support activities. Quality Technician III applies data‑driven and risk‑based thinking to resolve complex material and process issues, leads cross‑functional initiatives, mentors junior staff, and ensures compliance with FDA, ISO, and internal quality system requirements.

• Perform comprehensive inspections of high‑complexity components and assemblies using contact and non‑contact measurement systems (vision systems, CMMs, micrometers, optical comparators, etc.)
• Lead First Article Inspections (FAIs), ensuring completeness, accuracy, and proper documentation of results and deviations
• Develop, revise, and approve Quality Inspection Reports (QIRs) based on engineering drawings, risk, and inspection strategy
• Perform calibrations with limited to no oversight in accordance with calibration procedures and standards
• Execute initial and recalibration activities, including running simple CMM programs for calibration verification
• Train and mentor others on proper inspection and calibration techniques and best practices
• Maintain inspection and calibration equipment readiness and support asset lifecycle management at ATEC and supplier sites

• Oversee Nonconformance Report (NCR) processes, ensuring accurate documentation and proper handling of nonconforming material
• Support and contribute to MRB activities by providing inspection data, risk analysis, and technical recommendations
• Manage quarantine cage operations, including material organization, inventory accuracy, and cycle counting
• Lead and participate in risk assessment activities using advanced risk analysis tools and methodologies
• Develop and implement risk management strategies aligned with quality and business objectives
• Support CAPA and SCAR activities, including root cause identification, effectiveness checks, and prevention of recurrence
• Ensure full compliance with FDA regulations, ISO 13485, GMP, GDP, and traceability requirements

• Analyze inspection, calibration, and quality data to identify trends, risks, and improvement opportunities
• Apply statistical and analytical techniques to support data‑driven decision making
• Lead low to medium complexity continuous improvement initiatives through completion
• Develop and execute data strategies aligned with operational and business goals
• Collaborate cross‑functionally to improve inspection efficiency, risk‑based controls, and process capability

• Mentor and guide junior technicians and inspectors in technical, analytical, and compliance‑related activities
• Provide clarity and interpretation of regulatory and quality system requirements to team members
• Lead quality‑related projects with oversight from senior management, ensuring alignment with organizational objectives
• Conduct and facilitate meetings related to inspection, calibration, risk, and quality initiatives
• Communicate complex technical, risk, and compliance information clearly to cross‑functional teams and leadership
• Foster a culture of accountability, collaboration, continuous improvement, and ethical behavior

• Maintain a clean and organized workstation and file management system
• Actively practice and enforce 5S requirements
• Ensure proper GDP is maintained across all quality documentation
• Other duties as assigned

• Advanced inspection techniques and nonconformance handling methods.
• Project management.
• CQT, CQI, or CQA preferred.

• 8‑15+ years of experience in a manufacturing or inspection environment, particularly in regulated industries (e.g., medical devices, pharmaceuticals).

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or…