About the Role:

The Director of Quality in a manufacturing environment is responsible for leading and overseeing all quality assurance and quality control activities to ensure that products meet or exceed customer expectations and regulatory requirements. This role involves developing and implementing comprehensive quality management systems, driving continuous improvement initiatives, and fostering a culture of quality throughout the organization. The Director will collaborate closely with cross-functional teams including production, engineering, supply chain, and regulatory affairs to align quality objectives with business goals. They will also manage quality audits, supplier quality performance, and compliance with industry standards to mitigate risks and enhance product reliability. Ultimately, this position ensures that the manufacturing processes and outputs consistently deliver high-quality products that support the company's reputation and operational excellence.

Minimum Qualifications:

• Bachelor's degree in Engineering, Quality Management, or a related field.
• Minimum of 5 years of experience in quality management within a manufacturing environment, with at least 3 years in a leadership role.
• Strong knowledge of quality management systems such as ISO 9001, Six Sigma, or equivalent standards.
• Proven experience in leading quality assurance and control teams and managing complex quality projects.
• Excellent understanding of manufacturing processes, quality tools, and statistical analysis.

Preferred Qualifications:

• Master's degree in Engineering, Business Administration, or Quality Management.
• Certification such as Certified Quality Engineer (CQE), Six Sigma Black Belt, or ASQ Certified Manager of Quality/Organizational Excellence.
• Experience with advanced quality methodologies including Lean Manufacturing and Total Quality Management (TQM).
• Familiarity with regulatory requirements relevant to the manufacturing industry, such as FDA, ISO/TS standards, or other industry-specific certifications.
• Proven track record of successfully implementing quality improvement initiatives that resulted in measurable business impact.

Responsibilities:

• Develop, implement, and maintain the company's quality management system in compliance with industry standards and regulatory requirements.
• Lead and manage the quality assurance and quality control teams to ensure effective execution of quality processes and procedures.
• Drive continuous improvement initiatives by analyzing quality data, identifying root causes of defects, and implementing corrective and preventive actions.
• Collaborate with production, engineering, and supply chain teams to integrate quality considerations into product design, manufacturing processes, and supplier management.
• Oversee internal and external quality audits, manage non-conformance reports, and ensure timely resolution of quality issues.
• Establish and monitor key quality performance indicators (KPIs) to track progress and report on quality metrics to senior leadership.
• Manage supplier quality programs, including supplier audits, qualification, and performance monitoring to ensure compliance with quality standards.
• Provide training and development opportunities to quality team members to enhance their skills and knowledge.

Skills:

The Director of Quality utilizes strong leadership and communication skills daily to guide and motivate quality teams and collaborate effectively with cross-functional departments. Analytical skills are essential for interpreting quality data, identifying trends, and driving data-informed decisions to improve product quality and process efficiency. Expertise in quality management systems and methodologies enables the Director to design and implement robust quality frameworks that ensure compliance and continuous improvement. Problem-solving skills are critical for addressing complex quality issues, managing risk, and implementing corrective actions promptly. Additionally, project management skills support the coordination of quality initiatives, audits, and training programs to achieve organizational quality objectives.