Position Summary
The Director of Quality is responsible for developing, implementing, and maintaining a company-wide quality management system (QMS) that ensures products and services meet both internal standards and external regulatory requirements. This leader will drive a culture of continuous improvement, operational excellence, and compliance across all departments, fostering collaboration and accountability.

 

ESSENTIAL DUTIES AND OTHER RESPONSIBILITIES:

• Develop and oversee the execution of the company’s Quality Strategy aligned with business goals and customer expectations.
• Lead the design, implementation, and maintenance of the Quality Management System (QMS) in compliance with industry standards (e.g., ISO 9001, FDA, GMP, etc.as applicable).
• Set quality performance metrics and ensure consistent reporting and analysis to drive improvement initiatives.
• Partner with R&D, Manufacturing, Operations, Regulatory, and other departments to embed quality throughout the product lifecycle.
• Direct internal and external audit programs, ensuring readiness for customer, regulatory, and certification audits.
• Lead root cause analysis and corrective/preventive action (CAPA) processes to resolve quality issues.
• Manage and develop the Quality Assurance and Quality Control teams, fostering growth and high performance.
• Oversee supplier quality programs to ensure material and component compliance.
• Champion a culture of quality, safety, and continuous improvement at all levels of the organization.
• Prepare and present quality performance updates and strategic recommendations to senior leadership.

 

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field (Master’s preferred).
• 10+ years of progressive experience in quality management roles, with at least 5 years in a senior leadership position.
• Proven experience managing compliance with relevant quality standards (e.g., ISO, FDA, GMP, Six Sigma, etc.).
• Strong knowledge of quality tools and methodologies (e.g., Lean, Six Sigma, CAPA, FMEA, SPC).
• Demonstrated ability to lead cross-functional teams and influence change across an organization.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional communication and interpersonal abilities.
• Advanced level of knowledge of Word, Excel, Power Point and Outlook