Director of Quality

The Director of Quality is a strategic leader responsible for developing, implementing, and continuously improving the organization’s quality management systems. This role ensures products, services, and processes meet regulatory requirements, industry standards, and customer expectations while driving a culture of quality, operational excellence, and continuous improvement across the enterprise.

The Director of Quality is a strategic leader responsible for developing, implementing, and continuously improving the organization’s quality management systems. This role ensures products, services, and processes meet regulatory requirements, industry standards, and customer expectations while driving a culture of quality, operational excellence, and continuous improvement across the enterprise.

• Develop and execute a comprehensive quality strategy aligned with organizational goals.
• Serve as a key member of the leadership team, advising on quality risks, compliance, and performance.
• Build and lead high-performing quality teams across multiple locations or business units.
• Promote a culture of quality, accountability, and continuous improvement.

• Oversee the design, implementation, and maintenance of the Quality Management System (e.g., ISO, FDA, or industry-specific standards).
• Ensure compliance with all applicable regulatory and certification requirements.
• Lead internal and external audits, inspections, and certifications.
• Establish and maintain quality policies, procedures, and documentation.

• Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Analyze quality data and metrics to identify trends, root causes, and opportunities for improvement.
• Partner with Operations, Engineering, and Supply Chain to improve process efficiency and product quality.
• Lead corrective and preventive action (CAPA) processes.

• Ensure customer quality requirements and expectations are consistently met or exceeded.
• Oversee customer complaint resolution and root cause analysis.
• Manage supplier quality programs, including qualification, performance monitoring, and audits.
• Strengthen supplier partnerships to ensure consistent materials and service standards.

• Identify quality-related risks and implement mitigation strategies.
• Ensure compliance with all regulatory bodies and applicable laws.
• Lead risk assessments (FMEA, HACCP, etc., depending on industry).
• Maintain readiness for regulatory inspections and audits.

• Define and track key performance indicators (KPIs) for quality performance.
• Provide regular executive-level reporting on quality trends, risks, and improvements.
• Use data-driven insights to support strategic decision-making.

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field required.
• Master’s degree (MBA or technical discipline) preferred.

• 10+ years of progressive experience in quality management, including 5+ years in a leadership role.
• Experience in [insert industry: manufacturing, healthcare, biotech, food, etc.].
• Proven track record of implementing and improving QMS frameworks.
• Strong experience with regulatory and compliance standards (e.g., ISO 9001, FDA, GMP, etc.).

• ASQ Certified Quality Manager (CQM) or similar.
• Lean Six Sigma Black Belt or equivalent.