Director of Quality Compliance
Virtual Vocations Inc, New York, NY, United States
A company is looking for a Director, Quality Systems & Compliance.
Key Responsibilities
Lead the design, implementation, and continuous improvement of a unified, enterprise-wide Quality Management System (QMS) Develop and oversee the annual internal audit program and manage external audits/inspections Establish and report enterprise-level quality metrics and KPIs to support data-driven decision-making
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, or a related field 10+ years of quality and compliance experience in the medical device industry Deep understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and related global regulations Proven success in leading internal and external audit programs Experience in implementing or optimizing electronic Quality Management Systems (eQMS)
Lead the design, implementation, and continuous improvement of a unified, enterprise-wide Quality Management System (QMS) Develop and oversee the annual internal audit program and manage external audits/inspections Establish and report enterprise-level quality metrics and KPIs to support data-driven decision-making
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, or a related field 10+ years of quality and compliance experience in the medical device industry Deep understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and related global regulations Proven success in leading internal and external audit programs Experience in implementing or optimizing electronic Quality Management Systems (eQMS)