Director of Quality

Job Summary:

The Director of Quality is a strategic leader responsible for developing implementing and continuously improving the organizations 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.

• Bachelors degree in Engineering Quality Management Life Sciences or related field required.
• Masters 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.).