Quality Manager

Fathom Mfg•Round Rock, TX

11h

About The Position

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.

Requirements

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

Nice To Haves

ASQ certifications (CQE, CQM, or equivalent)
Experience with ERP/MRP systems
Experience with cleanroom or regulated manufacturing environments
Lean or continuous improvement background

Responsibilities

Own and maintain the site ISO 13485 Quality Management System
Ensure compliance with ISO 13485, FDA 21 CFR Part 820 (as applicable), and 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, and 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 and First Article Inspection (FAI) / PPAP (as required)
Ensure appropriate use and calibration of CMMs, Optical/Vision systems, and 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 and 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