Plant Quality Manager

We are seeking an experienced Quality Manager to lead the Quality functions within a regulated FDA manufacturing environment.

• Lead and develop site Quality Assurance and Quality Engineering teams.
• Ensure compliance with FDA, ISO 13485, MDR, and applicable quality regulations.
• Oversee CAPA, nonconformance management, material review boards, and quality investigations.
• Support product development and manufacturing through quality planning, statistical analysis, and process controls.
• Monitor quality metrics, department objectives, training programs, and continuous improvement initiatives.
• Lead internal, customer, and regulatory audits.
• Manage product and process quality issues using formal problem-solving methodologies.
• Partner with suppliers to improve product quality and resolve quality concerns.
• Provide leadership for validation, calibration, quality engineering, and related quality operations functions.

• Bachelor's degree in Engineering, Scientific Discipline, or related field.
• 7+ years of quality leadership experience in a regulated industry, with 4 years of management experience
• Must have a solid background in a regulated manufacturing environment, preferably medical devices.
• Strong working knowledge of FDA Quality System Regulations, ISO 13485, MDR, and quality management systems.
• Experience leading larger quality teams (20+ min) and supporting regulatory audits.
• Solid continuous improvement experience is preferred.
• Advanced statistical analysis and problem-solving skills.

Excellent compensation package including annual bonus and relocation is offered. Company has a comprehensive benefits package including medical, dental, vision, matching 401k and more.