Quality Assurance Director

Quality Assurance Director

Scientific Calibration – Cary, NC (Headquarters)

Scientific Calibration is seeking a driven and detail-oriented Quality Assurance Director to lead and continuously improve our Quality Management System at our Cary, NC headquarters. As a trusted provider of calibration and laboratory services, this role is critical in ensuring the accuracy, reliability, and compliance of the services we deliver to our clients.

This position is responsible for the implementation, maintenance, and ongoing enhancement of our laboratory Quality Management System, ensuring full compliance with all applicable regulatory standards and accreditations. The ideal candidate is a proactive leader with strong analytical skills, a data-driven mindset, and the ability to influence change across the organization.

Position Overview

The Quality Assurance Director will oversee all aspects of Scientific Calibration’s Quality Management System, ensuring operational excellence, regulatory compliance, and continuous improvement across laboratory and business processes.

Key Responsibilities

• Develop, implement, and maintain quality systems, processes, and procedures in alignment with applicable laboratory standards
• Ensure compliance with ISO/IEC 17025, GMP, GLP, and other applicable regulatory requirements
• Lead the creation, review, and approval of SOPs, records, and quality documentation
• Identify compliance gaps and implement risk-based corrective and preventive actions (CAPA)
• Monitor and maintain quality logs, records, and performance metrics for accuracy and completeness
• Partner cross-functionally to investigate nonconformances, deviations, and quality incidents
• Oversee internal audit programs and support client and regulatory audits
• Manage vendor qualification and assurance programs, including maintaining certificates of analysis
• Lead management review meetings and track key quality performance indicators (KPIs)
• Drive continuous improvement initiatives using data analysis and measurable outcomes
• Stay current with evolving industry regulations and standards, updating internal programs as needed
• Address internal and customer quality concerns through structured investigation and resolution processes
• Ensure adherence to company policies and promote a culture of quality and compliance

Qualifications

• Bachelor’s degree in a scientific, engineering, or related field
• 3–5 years of experience in a quality/regulatory role within a laboratory or regulated environment
• Demonstrated experience with ISO/IEC 17025 and ISO 8655 standards
• Strong background in audit management, quality systems, and regulatory compliance
• Proven ability to analyze data, identify trends, and drive risk-based decision-making
• Excellent communication and cross-functional collaboration skills

Why Scientific Calibration?

At Scientific Calibration, quality is at the core of everything we do. This role offers the opportunity to make a direct impact on the integrity of our services and the satisfaction of our clients, while helping shape and elevate our quality systems as we continue to grow.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Tuition reimbursement
• Vision insurance

Job Type: Full-time

Pay: $65,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience:

• Quality assurance: 3 years (Preferred)

Work Location: In person