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. Position Summary 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. Key Responsibilities Quality Management System (ISO 13485) Own and maintain the site ISO 13485 Quality Management SystemEnsure compliance with:ISO 13485FDA 21 CFR Part 820 (as applicable)Customer-specific quality requirementsDevelop, implement, and control quality policies, procedures, work instructions, and recordsManage document control and record retention systemsLead management reviews and track quality KPIs Audit & Regulatory Compliance Serve as primary point of contact for:ISO certification auditsCustomer auditsRegulatory inspectionsPlan, conduct, and document internal auditsDrive corrective actions resulting from audits to timely and effective closureMaintain audit readiness across all departments Nonconformance & CAPA Oversee Nonconformance (NCR) and CAPA processesLead root cause analysis using structured problem-solving tools (5 Whys, Fishbone, etc.)Ensure corrective and preventive actions are effective and sustainedTrack trends and drive systemic improvements Inspection & Metrology Lead inspection and measurement activities including:Incoming, in-process, and final inspectionFirst Article Inspection (FAI) / PPAP (as required)Ensure appropriate use and calibration of:CMMsOptical/Vision systemsHand gages (micrometers, calipers, height gages, etc.)Maintain calibration program for all measuring and test equipment Risk Management Ensure risk-based thinking is embedded into quality processesSupport risk analysis activities (process risk, supplier risk, change risk)Participate in change management reviews (process, tooling, material, suppliers) Supplier Quality Management Approve and monitor suppliers and special process vendorsConduct supplier audits as requiredManage supplier corrective actions and performance metricsEnsure material and process certifications meet customer and regulatory requirements Production & Cross-Functional Support Partner with Operations, Engineering, and Production to:Improve process capability and yieldReduce scrap and reworkSupport new product introductions (NPI)Participate in production meetings and support daily quality issuesEnsure quality expectations are clearly communicated to the shop floor Leadership & Team Development Lead and develop Quality Inspectors and Quality EngineersEstablish training requirements for quality personnelPromote a culture of quality ownership throughout the organizationSupport employee training related to ISO 13485 and quality procedures Required Qualifications Education & Experience 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 environmentHands-on experience with ISO 13485 (certified environment strongly preferred)Experience supporting medical device customers highly preferred Technical & Professional Skills Strong knowledge of:ISO 13485FDA QSR (21 CFR 820)GD&TStatistical methods and SPCExperience with CMM programming and metrology systemsProficiency with root cause analysis and CAPA methodologiesStrong documentation and technical writing skillsComfortable working in a fast-paced, job-shop or high-mix environment Leadership & Communication Confident audit leader and customer interfaceAbility to influence cross-functional teamsStrong organizational and prioritization skillsClear and effective communicator at all levels of the organization Preferred Qualifications ASQ certifications (CQE, CQM, or equivalent)Experience with ERP/MRP systemsExperience with cleanroom or regulated manufacturing environmentsLean or continuous improvement background Key Performance Indicators (KPIs) Audit performance and findingsNCR and CAPA closure effectivenessCustomer complaints and escapesScrap, rework, and cost of poor quality (COPQ)On-time calibration and document complianceWith 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/DisabledThis 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.