Quality Director

We are seeking a strategic and hands-on Quality Leader to drive enterprise-wide quality excellence across complex manufacturing operations. This role is responsible for shaping quality strategy, leading continuous improvement initiatives, ensuring compliance with critical regulatory and industry standards, and building a culture of operational excellence.

The ideal leader brings a balance of executive-level strategic thinking and practical execution, with deep expertise in regulated manufacturing environments, supplier quality, process optimization, and cross-functional leadership. This is an opportunity to make a meaningful impact by elevating quality systems, improving throughput, reducing defects, and strengthening organizational performance across the business.

Key Responsibilities

• Lead the overall quality function, including quality systems, compliance, reporting, and continuous improvement initiatives.
• Serve as the executive quality leader for ISO-certified quality management systems, including ISO 9001, ISO 13485, AS9100, and support environmental management initiatives aligned with ISO 14001.
• Act as Management Representative for applicable quality certifications, ensuring audit readiness and ongoing compliance.
• Drive enterprise quality planning for products, processes, and manufacturing operations.
• Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials.
• Establish and monitor quality KPIs, dashboards, and performance metrics to drive measurable improvement.
• Lead corrective and preventive action (CAPA) processes in partnership with Engineering, Manufacturing, and Operations.
• Partner with suppliers to strengthen supplier quality standards, compliance, and performance.
• Oversee calibration systems, preventive maintenance quality controls, and product/process quality assurance programs.
• Champion Lean, 6S, and operational excellence initiatives to improve quality, throughput, and efficiency.
• Develop and implement quality policies, procedures, and training programs to ensure consistent workmanship and adherence to standards.
• Promote awareness of customer, regulatory, and quality requirements throughout the organization.
• Ensure compliance with applicable regulatory frameworks including FDA, ITAR, IPC standards, and electronic manufacturing quality requirements.
• Lead, mentor, and develop quality teams while influencing cross-functional stakeholders at all levels.

Ideal Background

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
• 10+ years of progressive quality leadership experience in a regulated manufacturing environment.
• Deep experience with electronic manufacturing, aerospace, defense, medical device, or highly regulated production environments.
• Strong knowledge of:
  • ISO 9001 / ISO 13485 / AS9100 / ISO 14001
  • FDA quality and compliance requirements
  • ITAR regulations
  • IPC standards (including component identification, workmanship, inspection standards)
  • CAPA, MRB, supplier quality, calibration systems, and process quality controls
  • Lean Manufacturing / World Class Manufacturing / continuous improvement methodologies
• Proven ability to lead large teams and manage multiple technical initiatives simultaneously.
• Strong executive presence, communication skills, and the ability to influence across engineering, manufacturing, operations, and executive leadership.
• Strategic thinker with strong analytical problem-solving skills and a bias toward action.
• Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen.

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