Quality Manager

Company History Fathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 500,000 square feet of manufacturing capacity across 10 facilities, Fathom seamlessly blends in-house capabilities across plastic and metal additive technologies, CNC machining, injection molding & tooling, urethane casting, sheet metal fabrication, and design and engineering.

The Quality Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in compliance with ISO 13485
, applicable FDA regulations, and customer requirements. This role leads all quality functions within the CNC machine shop, ensuring consistent product conformity, regulatory compliance, and effective risk management across machining, finishing, inspection, and shipping operations.

The Quality Manager serves as the site authority during audits and is a key member of the leadership team, driving a culture of quality, accountability, and continuous improvement.

• Own and maintain the site ISO 13485 Quality Management System
• Ensure compliance with:
  • ISO 13485
  • FDA 21 CFR Part 820 (as applicable)
  • Customer-specific quality requirements
• Develop, implement, and control quality policies, procedures, work instructions, and records
• Manage document control and record retention systems
• Lead management reviews and track quality KPIs

• Serve as primary point of contact for:
  • ISO certification audits
  • Customer audits
  • Regulatory inspections
• Plan, conduct, and document internal audits
• Drive corrective actions resulting from audits to timely and effective closure
• Maintain audit readiness across all departments

• Oversee Nonconformance (NCR) and CAPA processes
• Lead root cause analysis using structured problem-solving tools (5 Whys, Fishbone, etc.)
• Ensure corrective and preventive actions are effective and sustained
• Track trends and drive systemic improvements

• Lead inspection and measurement activities including:
  • Incoming, in-process, and final inspection
  • First Article Inspection (FAI) / PPAP (as required)
• Ensure appropriate use and calibration of:
  • CMMs
  • Optical/Vision systems
  • Hand gages (micrometers, calipers, height gages, etc.)
• Maintain calibration program for all measuring and test equipment

• Ensure risk‑based thinking is embedded into quality processes
• Support risk analysis activities (process risk, supplier risk, change risk)
• Participate in change management reviews (process, tooling, material, suppliers)

• Approve and monitor suppliers and special process vendors
• Conduct supplier audits as required
• Manage supplier corrective actions and performance metrics
• Ensure material and process certifications meet customer and regulatory requirements

• Partner with Operations, Engineering, and Production to:
  • Improve process capability and yield
  • Reduce scrap and rework
  • Support new product introductions (NPI)
• Participate in production meetings and support daily quality issues
• Ensure quality expectations are clearly communicated to the shop floor

• Lead and develop Quality Inspectors and Quality Engineers
• Establish training requirements for quality personnel
• Promote a culture of quality ownership throughout the organization
• Support employee training related to ISO 13485 and quality procedures

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related field (or equivalent experience)
• 5+ years of quality leadership experience in a CNC machining or manufacturing environment
• Hands‑on experience with ISO 13485 (certified environment strongly preferred)
• Experience supporting medical device customers highly preferred

• Strong knowledge of:
  • ISO 13485
  • FDA QSR (21 CFR 820)
  • GD&T
  • Statistical methods and SPC
• Experience with CMM programming and metrology systems
• Proficiency with root cause analysis and CAPA…