Quality Assurance Director

Job Description

Job Description

The Quality Assurance Director is responsible for leading and executing the overall quality strategy across the organization. This role provides strategic direction, leadership, and oversight of all quality systems, ensuring products, processes, and services meet or exceed internal standards, customer expectations, and regulatory requirements. The Director drives a culture of continuous improvement, operational excellence, and compliance while partnering cross-functionally with Engineering, Manufacturing, Supply Chain, and Leadership to enhance product quality, efficiency, and customer satisfaction.

ESSENTIAL FUNCTIONS:

• Develop, implement, and continuously improve the company’s Quality Management System (QMS) to ensure alignment with business objectives and industry standards.
• Provide strategic leadership and direction for all quality functions, including Quality Assurance, Quality Control, Calibration, and Compliance.
• Establish long-term quality strategies, annual goals, and key performance indicators (KPIs); track progress and drive accountability across the organization.
• Ensure compliance with applicable standards and certifications, including ISO 9001, ISO 17025, ATEX, IECEx, and other regulatory requirements.
• Lead and oversee internal and external audits, including certification audits, customer audits, and supplier audits.
• Drive continuous improvement initiatives focused on reducing scrap, improving first-pass yield, increasing efficiency, and enhancing overall product quality.
• Partner with Engineering and Manufacturing to ensure robust design controls, process validation, and production quality standards are established and maintained.
• Review and interpret customer quality requirements, ensuring alignment and execution throughout the organization.
• Collaborate with Supply Chain and Purchasing to establish and enforce supplier quality standards; evaluate and improve supplier performance.
• Analyze quality data and metrics to identify trends, risks, and opportunities; present actionable insights to executive leadership.
• Lead root cause analysis and corrective/preventive action (CAPA) processes to resolve quality issues and prevent recurrence.
• Ensure all calibration systems, preventative maintenance activities, and document control processes are compliant and effectively managed.
• Develop and mentor quality team members, fostering a high-performance culture focused on accountability, development, and continuous improvement.
• Promote the use of quality tools and methodologies (e.g., Six Sigma, Lean, SPC, FMEA) across the organization.
• Lead the Annual Management Review and report on the overall effectiveness of the Quality Management System.
• Serve as the primary quality representative to executive leadership, customers, and regulatory bodies.

REQUIRED EDUCATION/EXPERIENCE:

• Bachelor’s degree in Engineering, Quality, or related discipline required; Master’s degree preferred.
• 8–12+ years of progressive experience in quality assurance within a manufacturing environment
• Minimum 5+ years in a leadership role managing quality teams
• Experience in precision manufacturing, instrumentation, or related industries preferred
• Strong experience with ISO standards and regulatory compliance

WORK ENVIRONMENT: The role requires regular movement between administrative offices and the manufacturing floor to support quality initiatives, collaborate with cross-functional teams, and ensure compliance with quality standards. Exposure to a production environment, including machinery, noise, and varying temperatures, is expected.

PHYSICAL DEMANDS:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. The employee must be able to lift and/or move items over 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

AAP/EEO STATEMENT:  All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employment is contingent upon passing a background check and a drug screen.

** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice **