Quality Manager

Position Summary

The Quality Manager is responsible for developing, implementing, and maintaining the organization's Quality Management System (QMS) to ensure compliance with DFARS, ITAR, ISO standards, customer requirements, and all applicable regulatory requirements. This role provides leadership to the quality organization while partnering with manufacturing, engineering, supply chain, and executive leadership to drive continuous improvement, operational excellence, and customer satisfaction.

The ideal candidate possesses extensive experience within highly regulated manufacturing environments supporting aerospace, defense, and/or medical device customers and has demonstrated success leading internal and external audits, managing customer quality expectations, and fostering a culture of quality throughout the organization.

Essential Responsibilities

Quality Management System

• Lead and maintain the Quality Management System (QMS) in accordance with ISO 9001 and/or AS9100 standards.
• Ensure organizational compliance with DFARS, ITAR, and applicable federal acquisition regulations.
• Maintain all quality policies, procedures, work instructions, and records.
• Prepare for and lead certification, surveillance, customer, and regulatory audits.
• Manage document control and change management processes.

Regulatory & Compliance

• Ensure ongoing compliance with:
  • DFARS requirements
  • ITAR regulations
  • ISO 9001 (AS9100 experience preferred)
  • Customer-specific quality requirements
  • Applicable FAR clauses
• Coordinate responses to regulatory findings and customer audits.
• Develop corrective action plans and verify effectiveness.

Leadership

• Lead, mentor, and develop quality personnel.
• Provide technical guidance to manufacturing and engineering teams.
• Support indirect quality staff by coaching and assisting with inspections, investigations, root cause analysis, and continuous improvement initiatives.
• Promote a culture of accountability and continuous improvement.

Continuous Improvement

• Lead Corrective and Preventive Action (CAPA) activities.
• Utilize Lean Manufacturing and Six Sigma methodologies to improve quality performance.
• Conduct Root Cause Analysis using structured methodologies including:
  • 8D
  • 5 Why
  • Fishbone
  • FMEA
• Drive measurable improvements in:
  • Scrap reduction
  • Customer complaints
  • First Pass Yield
  • Cost of Quality
  • On-Time Delivery
  • Supplier Quality

Customer Quality

• Serve as the primary quality representative with customers.
• Respond to customer concerns and nonconformance reports.
• Coordinate customer audits and quality surveys.
• Develop action plans to improve customer satisfaction.

Supplier Quality

• Evaluate and approve suppliers.
• Monitor supplier performance metrics.
• Conduct supplier audits as necessary.
• Collaborate with Supply Chain to resolve supplier quality issues.

Production Support

• Ensure manufacturing processes meet quality requirements.
• Review manufacturing documentation for compliance.
• Oversee nonconforming material processes.
• Support production readiness for new product introductions.

Metrics & Reporting

Develop and present quality metrics including:

• Customer PPM
• Internal PPM
• Cost of Poor Quality
• First Pass Yield
• Audit Results
• Corrective Action Aging
• Supplier Performance
• Customer Satisfaction
• Calibration Compliance
• Internal Audit Performance

Provide monthly quality reports to executive leadership.