Quality Director

About This Role

Leading the organization's quality management initiatives is the core of this pivotal role, driving the development, implementation, and continuous improvement of quality systems across all manufacturing and production processes. This role offers an exciting opportunity to shape quality culture, influence strategic decisions, and foster cross-functional collaboration to achieve operational excellence.

Responsibilities

• Develop, implement, and oversee comprehensive quality management systems aligned with ISO 9001, ISO 13485 (medical devices), GMP (Good Manufacturing Practices), FDA regulations, and other relevant standards
• Lead internal and external quality audits to ensure compliance with regulatory and legal standards in production environments
• Establish and monitor quality standards in production processes, ensuring consistency, safety, and reliability of products
• Drive continuous improvement initiatives utilizing Six Sigma methodologies and lean management principles to optimize manufacturing efficiency and reduce waste
• Manage quality control teams responsible for inspection, testing, and validation activities including GDT (Geometric Dimensioning & Tolerancing) practices
• Collaborate with cross-functional teams such as manufacturing, engineering, regulatory affairs, and supply chain to ensure seamless integration of quality systems
• Lead investigations into quality issues or non-conformances, implementing corrective and preventive actions (CAPA) to prevent recurrence
• Maintain up-to-date knowledge of industry regulations including FDA regulations, GMP standards, HACCP (Hazard Analysis Critical Control Point), CGMP (Current Good Manufacturing Practices), and other legal requirements relevant to the organization’s products

Requirements

• Proven experience practicing in an industrial or manufacturing engineering role with a strong focus on quality assurance and control
• Extensive knowledge of ISO 9001, ISO 13485, GMP, FDA regulations, HACCP, CGMP standards, and related regulatory/legal compliance standards
• Demonstrated expertise in conducting quality audits and implementing quality systems within manufacturing environments
• Strong analysis skills with proficiency in root cause analysis, problem-solving techniques, and data-driven decision making
• Leadership experience managing cross-functional teams with excellent communication skills to foster collaboration across departments
• Familiarity with GD&T principles for precise measurement and manufacturing tolerances
• Project management skills with the ability to lead multiple initiatives simultaneously while maintaining attention to detail

Nice to have:

• Certification in Six Sigma (Green Belt or Black Belt preferred) or other process improvement methodologies