Quality Manager

Work Location: Lynchburg County, Virginia

Summary:

Seeking an experienced professional to lead and manage quality systems, ensuring compliance with ISO, AS, and GMP standards. This role is responsible for developing and implementing quality strategies, overseeing audits, and driving continuous improvement initiatives within a manufacturing environment.

Responsibilities:

• Lead the development, implementation, and maintenance of quality management systems in alignment with ISO, AS, and GMP requirements.
• Design and execute quality strategies and plans, integrating them with organizational objectives and long-term goals.
• Oversee performance measurement systems, analyze production data, and drive quality trending and improvement projects.
• Coordinate and manage cross-functional teams for project planning, scheduling, and resource allocation to achieve quality objectives.
• Provide expertise in quality engineering for equipment and product development, including validation, documentation, and training.
• Ensure compliance with external standards, regulatory requirements, and internal quality management systems, including audit readiness.
• Investigate and resolve product issues, lead corrective and preventive actions, and manage customer communications related to quality.
• Serve as the process owner for key ISO 13485 elements, maintain calibration and document control systems, and report on quality system effectiveness to leadership.

Qualifications:

• Bachelor’s degree or equivalent work experience.
• At least five years of experience in quality assurance or quality control, with strong organizational and leadership skills.
• Professional background in production or manufacturing, particularly with assembly line processes; supervisory experience required.
• Comprehensive knowledge of quality principles, ISO 13485, AS9100, and ISO 14001 standards, and regulatory compliance.
• Proficiency in computer use, data analysis, and operation of measuring equipment.
• Excellent mathematics, reading, and writing skills.
• Strong organizational, prioritization, teamwork, analytical, critical-thinking, and problem-solving abilities.
• Ability to manage audits, interpret standards, and act as a liaison for quality management system matters.

Published Category: Quality & Validation