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A healthcare and human tissue distribution organization is seeking a Quality Manager to support the sustainment, improvement, and globalization of its Quality Management System (QMS). This role is responsible for ensuring compliance with FDA regulations, ISO 13485 standards, and internal quality policies while serving as a subject matter expert to internal stakeholders and external regulators. The Quality Manager will lead nonconformance investigations, corrective action planning, quality risk assessments, training compliance, and continuous improvement initiatives. Working closely with Operations Managers, this individual will help ensure day-to-day activities meet regulatory requirements while identifying opportunities to enhance quality processes, operational efficiency, and compliance.
Key responsibilities include maintaining and managing the QMS, leading root cause investigations and corrective actions, overseeing quality and training records, supporting external audits, and providing quality-related training and guidance to operations teams. The Quality Manager will collaborate across departments to promote a culture of quality, monitor compliance metrics and NCR trends, and provide recommendations to senior leadership for ongoing process improvement. This position requires a strong understanding of healthcare and human tissue distribution, including storage protocols, Customs and Border Protection (CBP) procedures, and international and domestic shipping regulations.
Qualified candidates will possess a bachelor's degree in quality management, Engineering, Life Sciences, or a related field and at least five years of quality management experience within the medical device industry or another regulated environment. Candidates must have demonstrated experience with Quality Management Systems, ISO 13485, FDA regulations, nonconformance reporting, root cause analysis, and corrective action programs. Strong written and verbal communication skills, proficiency with Microsoft Office, and the ability to lift up to 50 pounds are required. Advanced quality certifications such as Certified Quality Auditor (CQA) or Six Sigma are preferred.