Quality Manager

**SUMMARY:

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The Quality Manager leads quality assurance activities for precision machined medical components. This role is responsible for maintaining compliance with ISO 13485, ISO 9001, applicable FDA regulations, ITAR requirements, customer specifications, and internal quality standards. The position partners with manufacturing, engineering, suppliers, and customers to ensure product conformity, regulatory compliance, process control, and continuous improvement.

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**ESSENTIAL DUTIES AND RESPONSIBILITIES

**include but are not limited to:

• Lead and maintain the Quality Management System in compliance with ISO 13485, ISO 9001, FDA regulations, ITAR requirements, customer specifications, and internal procedures.

• Support quality assurance for precision machined medical components, including inspection planning, process controls, nonconforming material, CAPA, audits, supplier quality, and customer quality requirements.

• Partner with manufacturing, engineering, suppliers, and customers to resolve quality issues, reduce defects, improve processes, and support product launch and production activities.

• Prepare for and support ISO, customer, regulatory, supplier, and ITAR-related audits.

• Oversee metrology, gage calibration, dimensional inspection, print reading, GD&T interpretation, and measurement system activities.

• Review and approve quality documentation, including inspection plans, control plans, work instructions, validation records, first article inspections, and engineering changes.

• Use quality data, statistical methods, capability studies, and measurement system analysis to drive continuous improvement.

• Manage, train, and develop Quality Department personnel to support manufacturing and compliance requirements.

**SKILLS AND ABILITIES:

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• Strong background in ISO 13485, ISO 9001, ITAR compliance, applicable FDA regulations, customer requirements, and regulated manufacturing documentation.

• Experience supporting quality systems in precision machining, medical device, aerospace, defense, or another regulated manufacturing environment.

• Hands-on knowledge of metrology, calibration, dimensional inspection, print reading, blueprint interpretation, GD&T, CMM or optical inspection, and measurement system analysis.

• Ability to lead teams, communicate with customers and auditors, solve problems, analyze quality data, and drive continuous improvement.

• Key competencies include accountability, collaboration, effective communication, customer focus, decision quality, process improvement, and results orientation.

**EDUCATION and/or EXPERIENCE

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• Bachelor’s degree in Quality, Engineering, Manufacturing, Operations, or a related technical field preferred; equivalent experience may be considered.

• Five or more years of progressive quality experience in precision machining, medical device, aerospace, defense, or another regulated manufacturing environment preferred.

• Experience 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.

• Proficient in standard Microsoft Office applications and capable of using quality management, calibration, inspection, data analysis, and enterprise systems as required.