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Quality Manager

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New York Embroidery Studio

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Location:
United States , Brooklyn

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Category:
Manufacturing

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Contract Type:
Employment contract

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Salary:

70000.00 - 75000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • Lead the implementation and ongoing maintenance of the QMS, ensuring full compliance with ISO 13485 standards
  • Manage all internal and external audits, including preparing for site readiness, coordinating execution, and ensuring timely follow-up on corrective actions
  • Oversee document control systems, change management procedures, and the maintenance of accurate training records
  • Direct and supervise Quality Team personnel to ensure flawless execution of inspection protocols, documentation standards, and product traceability
  • Oversee the Corrective and Preventive Action (CAPA) program and lead root cause analysis for all non-conformances
  • Partner with Production, Engineering, and Supply Chain departments to integrate quality standards into all operational workflows
  • Track, analyze, and report on key quality metrics (KPIs), including defect rates, audit findings, and customer complaints
  • Foster a company-wide culture of quality, regulatory compliance, and proactive process optimization

Requirements:

  • Degree in Textile Science, Physical Science, Business Management, or a related field
  • Proven ability to manage teams, communicate effectively across levels, and lead complex organizational initiatives
  • Strong capability in data analysis, risk identification, and the implementation of effective, scalable solutions
  • Proficiency in core quality tools including: CAPA (Corrective and Preventive Action), Risk Management, Root Cause Analysis, Document Control
  • Familiarity with FDA, MDSAP, or CE regulatory frameworks
  • Experience utilizing electronic QMS (eQMS) platforms or validation systems
  • Bilingual proficiency (English/Chinese) is considered a significant asset

Nice to have:

  • Familiarity with FDA, MDSAP, or CE regulatory frameworks
  • Experience utilizing electronic QMS (eQMS) platforms or validation systems
  • Bilingual proficiency (English/Chinese) is considered a significant asset

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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