ISO 13485 Quality Leader & QMS Manager

American Society for Quality; New York (NY); On-site; USD 110,000 - 150,000; Full time

Job summary

American Society for Quality in New York, NY seeks a Quality Manager to lead the QMS implementation in line with ISO 13485 and ensure quality compliance across all departments. You will oversee audits, document control, CAPA, training records, and change management while collaborating with Production, Engineering, and Supply Chain to embed quality into daily operations.

This middle-management role reports to the Quality Director and drives data-driven improvement, tracks metrics, and fosters a

Qualifications

• Requires leadership, organizational, and communication skills.
• Experience applying CAPA, risk management, root cause analysis, and document control.
• Familiarity with ISO 13485, FDA/MDSAP, or CE regulatory frameworks is preferred.

Responsibilities

• Lead and oversee the implementation and maintenance of the QMS in compliance with ISO 13485 standards.
• Supervise Quality Team personnel and ensure execution of inspection, documentation, and traceability procedures.
• Manage internal and external audits, including audit readiness, follow-ups, and corrective actions.
• Ensure document control systems, change management procedures, and training records are current and compliant.
• Oversee CAPA processes and support root cause analysis for non-conformances.
• Collaborate with Production, Engineering, Supply Chain, and other departments to ensure quality is built into all operations.
• Track and report on key quality metrics and trends, including defect rates, audit findings, and customer complaints.
• Foster a culture of quality, compliance, and continuous improvement throughout the organization.

Skills

Leadership

Communication

Data analysis

Risk management

CAPA

Document control

Cross-functional collaboration

Education

Bachelor's degree in Textile, physical science, business management, or related field

Tools

QMS platforms

Validation systems

Job description

American Society for Quality in New York, NY seeks a Quality Manager to lead the QMS implementation in line with ISO 13485 and ensure quality compliance across all departments. You will oversee audits, document control, CAPA, training records, and change management while collaborating with Production, Engineering, and Supply Chain to embed quality into daily operations.

This middle-management role reports to the Quality Director and drives data-driven improvement, tracks metrics, and fosters a