Quality Manager

Job SummaryThe 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 ResponsibilitiesQMS & Regulatory ComplianceSystem 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 LeadershipTeam 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 & CultureMetrics & 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.RequirementsEducation: 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 ManagementRoot Cause AnalysisDocument ControlPreferred AttributesRegulatory 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, NYReporting to: Quaility DirectorExperience Level: 2–4 YearsCompensation: $70,000-$75,000Salary Commensurate with Experience and QualificationsAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.