Quality 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

Job Title: Quality Manager

Position Summary:

The Quality Manager plays a key leadership role in overseeing the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485. As part of middle management, this role ensures quality compliance across all departments, manages quality processes and audits, and supports continuous improvement initiatives. The Quality Manager reports directly to the Quality Director and serves as a liaison between upper leadership and operations teams to ensure product quality, regulatory alignment, and process integrity.

Reports to: Quality Director

Key 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 (Corrective and Preventive Action) 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.

Qualifications:

• Textile, physical science, business management, or related degree.
• Strong leadership, organizational, and communication skills.
• Ability to analyze data, identify risks, and implement effective solutions.
• Understanding of quality tools such as CAPA, risk management, root cause analysis, and document control.

Preferred Attributes:

• Experience with FDA, MDSAP, or CE regulatory frameworks.
• Proficiency with electronic QMS platforms or validation systems.
• Bilingual (English/Chinese) is a plus.