Site CAPA Leader/ Quality Culture/ Systems

BD seeks a Site CAPA Leader to oversee corrective and preventive action processes at a medical device manufacturing facility in Columbus. The role combines quality system oversight, continuous improvement leadership, and regulatory compliance responsibility.

Responsibilities

• Own and manage the CAPA process across the manufacturing unit
• Lead quality and process improvement initiatives using continuous improvement techniques
• Review and develop changes to existing or proposed processes to optimize performance and cost
• Ensure regulatory compliance and conduct staff training on medical device requirements
• Support internal and external audits and assist with equipment validation

Requirements

• Bachelor of Science degree
• 5 years manufacturing experience with broad process background
• 3 years CAPA process experience
• 2 years quality manufacturing experience
• Proven track record using Six Sigma, Green Belt, or Black Belt methodologies
• 3 years practical GMP and medical device manufacturing experience
• Medical device manufacturing industry background

Compensation: Competitive pay