Quality Manager at Fathom Mfg – Round Rock, Texas

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 methodologies

• Strong documentation and technical writing skills

• Comfortable working in a fast-paced, job-shop or high-mix environment

• Confident audit leader and customer interface

• Ability to influence cross-functional teams

• Strong organizational and prioritization skills

• Clear and effective communicator at all levels of the organization

• ASQ certifications (CQE, CQM, or equivalent)

• Experience with ERP/MRP systems

• Experience with cleanroom or regulated manufacturing environments

• Lean or continuous improvement background

• Audit performance and findings

• NCR and CAPA closure effectiveness

• Customer complaints and escapes

• Scrap, rework, and cost of poor quality (COPQ)

• On-time calibration and document compliance

With over 50 years of industry experience, Fathom is at the forefront of the industry 4.0 digital manufacturing revolution serving clients in the technology, defense, aerospace, medical, automotive and IOT sectors. Fathom’s extensive certifications include ISO 9001:2015, ISO 9001:2015 Design, ISO 13485:2016, AS9100:2016, NIST 800-171 and ITAR.

Equal Opportunity Employer/Veterans/Disabled

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.