Quality Systems Manager -- Medical Precision Machining

Picture a typical morning: you review capability studies and MSA dashboards, scan open CAPAs, and triage a supplier nonconformance while preparing the team for a customer audit. Before lunch, you walk the floor to verify process controls on a new precision-machined medical component and consult on a tricky GD&T callout. In the afternoon, you close the loop on inspection planning for a product launch and sign off on validation records. That blend of rigor, coaching, and hands-on problem solving is the heartbeat of this Quality Systems Manager role.

• End-to-end stewardship of the Quality Management System aligned to ISO 13485 and ISO 9001, and compliant with FDA regulations, ITAR requirements, customer specifications, and internal procedures.
• Quality assurance for precision machined medical components: inspection planning, process controls, disposition of nonconforming material, CAPA, internal and external audits, supplier quality, and customer-specific quality needs.
• Cross-functional problem solving with manufacturing, engineering, suppliers, and customers to resolve issues, reduce defects, improve processes, and support both product launches and steady-state production.
• Audit readiness and support for ISO, customer, regulatory, supplier, and ITAR-related assessments.
• Ownership of metrology and measurement systems: gage calibration, dimensional inspection, blueprint interpretation, GD&T, and use of CMM or optical inspection methods.
• Formal review and approval of quality documentation including inspection and control plans, work instructions, validation records, first article inspections, and engineering change-related quality updates.
• Data-driven improvement using statistical methods, capability analysis, and measurement system analysis to drive measurable gains in quality performance.
• People leadership: manage, train, and develop Quality team members to elevate capability and meet compliance and manufacturing requirements.

• Deep working knowledge of ISO 13485, ISO 9001, ITAR, applicable FDA regulations, customer requirements, and documentation practices for regulated manufacturing.
• Background in precision machining and experience in regulated environments such as medical devices, aerospace, or defense.
• Hands-on metrology expertise, including calibration, dimensional inspection, blueprint reading, GD&T interpretation, and use of CMM or optical systems; strong grasp of MSA principles.
• Strength in team leadership, customer and auditor communication, structured problem solving, and using quality data to drive continuous improvement.
• Core competencies: accountability, collaboration, effective communication, customer focus, decision quality, process improvement, and results orientation.

• Bachelor’s degree in Quality, Engineering, Manufacturing, Operations, or a related technical field preferred; equivalent experience considered.
• 5+ years of progressive quality experience within precision machining, medical device, aerospace, defense, or similarly regulated manufacturing.
• Proficiency with ISO 13485, ISO 9001, FDA-regulated processes, ITAR-controlled work, audits, supplier quality, CAPA, metrology, calibration, dimensional inspection, print reading, GD&T, and quality planning.
• Comfort with Microsoft Office and fluency with quality management, calibration, inspection, data analysis, and enterprise systems.