Table of Contents
Job Summary
The Quality Manager serves as a pivotal leader responsible for the implementation and maintenance of the Quality Management System (QMS) in strict accordance with ISO 13485 standards. Acting as a liaison between upper leadership and operations, this role ensures cross-departmental compliance, manages rigorous auditing processes, and spearheads continuous improvement initiatives to maintain product quality and process integrity.
Key Responsibilities
QMS & Regulatory Compliance
System Oversight: Lead the implementation and ongoing maintenance of the QMS, ensuring full compliance with ISO 13485 standards.
Audit Management: Manage all internal and external audits, including preparing for site readiness, coordinating execution, and ensuring timely follow-up on corrective actions.
Documentation & Change Control: Oversee document control systems, change management procedures, and the maintenance of accurate training records.
Quality Operations & Team Leadership
Team Supervision: Direct and supervise Quality Team personnel to ensure flawless execution of inspection protocols, documentation standards, and product traceability.
CAPA & Root Cause Analysis: Oversee the Corrective and Preventive Action (CAPA) program and lead root cause analysis for all non-conformances.
Cross-Functional Collaboration: Partner with Production, Engineering, and Supply Chain departments to integrate quality standards into all operational workflows.
Performance & Culture
Metrics & Reporting: Track, analyze, and report on key quality metrics (KPIs), including defect rates, audit findings, and customer complaints.
Continuous Improvement: Foster a company-wide culture of quality, regulatory compliance, and proactive process optimization.
Requirements
Core Requirements
Education: Degree in Textile Science, Physical Science, Business Management, or a related field.
Leadership: Proven ability to manage teams, communicate effectively across levels, and lead complex organizational initiatives.
Analytical Skills: Strong capability in data analysis, risk identification, and the implementation of effective, scalable solutions.
Technical Knowledge: Proficiency in core quality tools including:
CAPA (Corrective and Preventive Action)
Risk Management
Root Cause Analysis
Document Control
Preferred Attributes
Regulatory Experience: Familiarity with FDA, MDSAP, or CE regulatory frameworks.
Systems Proficiency: Experience utilizing electronic QMS (eQMS) platforms or validation systems.
Language: Bilingual proficiency (English/Chinese) is considered a significant asset.
Why Join us?
This role offers the chance to lead a distinct and meaningful functional area within our company. Your work will directly impact the safety of healthcare workers and laborers by ensuring they have access to verified, high-quality protective equipment.
Location: Brooklyn, NY
Reporting to: Quaility Director
Experience Level: 2–4 Years
Compensation: $70,000-$75,000
Salary Commensurate with Experience and Qualifications
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.
To apply click here