Director of Quality

• Establish and maintain a robust quality management system that encompasses quality assurance, quality control, and continuous improvement processes.
• Lead and mentor a team of quality professionals, providing guidance, coaching, and support to drive performance excellence.
• Define key performance indicators (KPIs) and metrics to monitor and evaluate quality performance across the organization.
• Collaborate with cross-functional teams to identify and implement best practices for quality assurance and control throughout the product lifecycle.
• Drive a culture of quality excellence by promoting awareness, accountability, and ownership of quality throughout the organization.
• Ensure compliance with regulatory requirements, industry standards, and customer specifications, including FDA regulations, ISO standards, and other relevant quality standards.
• Lead audits and inspections by regulatory agencies, customers, and third-party organizations, and drive corrective and preventive actions as necessary.
• Partner with suppliers and vendors to establish quality standards and requirements for incoming materials and components.
• Oversee the investigation and resolution of product quality issues, customer complaints, and non-conformances, ensuring root cause analysis and corrective actions are implemented effectively.
• Develop and deliver quality-related training programs to enhance the capabilities of employees across the organization.
• Stay abreast of emerging trends, technologies, and regulations in quality management and recommend appropriate actions to maintain a competitive advantage.

• Minimum of [X] years of progressive experience in quality management roles, with a track record of increasing responsibility and leadership.
• Strong understanding of quality management principles, methodologies, and tools, such as Six Sigma, Lean, and Total Quality Management.
• Proven experience developing and implementing quality management systems, such as ISO 9001, ISO 13485, or similar standards.
• Excellent leadership, strategic planning, and interpersonal skills, with the ability to influence and inspire teams at all levels of the organization.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making.
• Experience leading quality initiatives in regulated industries, such as healthcare, pharmaceuticals, or medical devices, is preferred.
• Certification in quality management (e.g., Certified Quality Manager, Six Sigma Master Black Belt) is a plus.

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