Quality Manager

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

Brooklyn, NY On-site Full-time Monday–Friday Posted October 30, 2026 Reports to Quality Director Salary Range: $70,000–$85,000 annually, commensurate with experience and qualifications

Job Summary

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

• 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 alloperations.
• 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.

Requirements

• Experience with FDA, MDSAP, or CE regulatory frameworks.
• 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.
• Proficiency with electronic QMS platforms or validation systems.
• Bilingual skills in Spanish or Chinese are a strong plus.

What You’ll Gain

Learn from a veteran Lead with 5–10 years of specialized PPE experience.

A clear career path

This isn’t just a job; it’s a prepared seat. We’re looking for the person who will eventually run this department.

Don’t See Your Role?

We’re always glad to meet talented people

If you’re passionate about American-made PPE and think you’d be a fit, we’d like to hear from you.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.