ATEC Spine · 6 hours ago
Quality Technician III
ATEC Spine is a company focused on quality in the medical device industry, and they are seeking a Quality Technician III to contribute strategically within their Quality organization. This role involves advanced inspection, calibration, risk management, and ensuring compliance with regulatory standards while mentoring junior staff.
Health CareMedical DeviceProduct Design
Responsibilities
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
Qualification
Required
Advanced inspection techniques and nonconformance handling methods
Project management
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 vaccination requirements (including the COVID-19 vaccine, as applicable)
Preferred
CQT, CQI, or CQA preferred
Benefits
Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Free Food & Snacks
Wellness Resources
Stock Option Plan
Company
ATEC Spine
ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation.
H1B Sponsorship
ATEC Spine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (5)
2023 (5)
2022 (2)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.02BKey Investors
Squadron Medical Finance Solutions
2025-03-03Post Ipo Debt· $350M
2023-10-24Post Ipo Equity· $150M
2023-04-19Post Ipo Equity· $60M
Recent News
MarketScreener
2025-11-03
2025-11-01
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