ISO 13485 Quality Manager | QMS & Audit Lead

NYES Protect; New York (NY); On-site; USD 70,000 - 85,000; Full time

Job summary

NYES Protect in Brooklyn, NY seeks a Quality Manager to lead QMS implementation and maintenance in line with ISO 13485. You will oversee quality processes, audits, and CAPA, reporting to the Quality Director and aligning operations with regulatory requirements.

As a middle manager, you will collaborate with Production, Engineering, and Supply Chain to build quality into all processes, track key metrics, and drive continuous improvement across the organization.

Qualifications

• Experience with FDA, MDSAP, or CE regulatory frameworks.
• Degree in textile, physical science, business management, or related field.
• Strong leadership, organizational, and communication skills.
• Ability to analyze data, identify risks, and implement effective solutions.
• Understanding of CAPA, risk management, root cause analysis, and document control.
• Proficiency with electronic QMS platforms or validation systems.
• Bilingual skills in Spanish or Chinese are a strong plus.

Responsibilities

• Lead and oversee QMS implementation and maintenance per ISO 13485.
• Supervise Quality Team and ensure inspection, documentation, traceability procedures.
• Manage internal and external audits, audit readiness, 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

Regulatory knowledge

Problem solving

Education

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

Tools

Electronic QMS platforms

Validation systems

Job description

NYES Protect in Brooklyn, NY seeks a Quality Manager to lead QMS implementation and maintenance in line with ISO 13485. You will oversee quality processes, audits, and CAPA, reporting to the Quality Director and aligning operations with regulatory requirements.

As a middle manager, you will collaborate with Production, Engineering, and Supply Chain to build quality into all processes, track key metrics, and drive continuous improvement across the organization.