Direct Relief · 16 hours ago
Quality Specialist
Direct Relief is a medical aid nonprofit dedicated to improving health and lives affected by poverty or emergencies. The Quality Specialist will manage the Quality Management System, lead discrepancy investigations, and support quality program initiatives to enhance operational efficiency and ensure compliance with industry standards.
Responsibilities
Lead discrepancy investigations, including root cause assignment, CAPA creation, and CAPA completion timelines
Support quality program initiatives across administrative functions, including process development and continuous improvement initiatives
Participate in teams’ initiatives that identify and eliminate internal process limitations and inefficiencies
Support the management of the electronic Quality Management System, including workflow development, and staff training
Collaborate with teams to develop effective training programs, including training documents, effectiveness checks, and other best practices
Support the growth and management of the supplier approval program
Develop, implement, and monitor product quality initiatives as part of the supplier approval program
Support and participate in supplier audits, including 3PL site visits
Qualification
Required
Knowledge of and experience with Supply Chain Management, Warehousing, Distribution, and Logistics in an FDA-regulated industry required with a sound understanding of GDP
Solid working experience in a position related to Quality Management Systems, including good understanding of requirements for documentation and training management in GxP environment
Good working business process knowledge of procurement, operations, warehousing, and order fulfillment
Bachelor's Degree
3+ Years of related experience
Proficient in working with Microsoft Word, Excel, Visio, PowerPoint and SharePoint
Strong data analysis, data management, and quantitative skills
Must have a collaborative work style
Must possess strong analytical and problem-solving skills
Must be a team player with strong verbal and written communication skills
Must have a commitment to high standards of professionalism and integrity
Must be patient and work with users to help them understand and learn concepts at a pace that matches individual skills
Ability to work independently with minimum supervision
Detail oriented with the ability to take initiative and work independently
General knowledge of electronic quality systems (MasterControl preferred), ERP systems (SAP preferred), computer-based management systems, ISO standards, and application of FDA regulations for applicable products preferred
Preferred
Knowledge of Lean and Six Sigma principles and experience using those tools in improvement activities preferred
Knowledge of best practices for employee training programs
Company
Direct Relief
Direct Relief is a humanitarian medical aid organization.
Funding
Current Stage
Growth StageRecent News
2025-12-18
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