Regional QMS & CAPA Leader

Becton, Dickinson and Company (BD); Plainfield (IN); In loco; USD 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

Becton, Dickinson and Company (BD) is seeking a Quality Management System professional to drive compliance with FDA 21 CFR 820 and ISO 13485 across the North America region. You will own CAPA processes, mentor regional teams, and lead cross-functional initiatives to strengthen quality programs.

The role emphasizes investigation management, root cause analysis, and corrective action execution within a fast-paced healthcare environment. On-site collaboration is required for most roles.

Competenze

• Degree level qualification or equivalent
• Experience with FDA 21 CFR 820 and ISO 13485 preferred
• Strong analytical and problem-solving abilities

Mansioni

• Support development and maintenance of QMS processes to ensure compliance
• Serve as Regional Site CAPA Lead for North America with investigation management and RCA
• Mentor NA regional teams on QMS requirements including Nonconformance and Audit processes
• Lead monthly NA Region Nonconformance Coach meetings for consistency and issue resolution
• Ensure regional procedures align with global QMS standards and regulatory requirements
• Assist internal/external QMS audits and drive corrective actions for continuous improvement

Conoscenze

QMS knowledge

Regulatory knowledge

CAPA

Formazione

Bachelor's degree or equivalent

Descrizione del lavoro

Becton, Dickinson and Company (BD) is seeking a Quality Management System professional to drive compliance with FDA 21 CFR 820 and ISO 13485 across the North America region. You will own CAPA processes, mentor regional teams, and lead cross-functional initiatives to strengthen quality programs.

The role emphasizes investigation management, root cause analysis, and corrective action execution within a fast-paced healthcare environment. On-site collaboration is required for most roles.