Quality Specialist

About us:

Direct Relief is a medical aid nonprofit, active in all 50 states and more than 80 countries, with a mission to improve the health and lives of people affected by poverty or emergencies – without regard to politics, religion, or ability to pay. 

Since its founding in 1948 by refugees of WWII, Direct Relief has grown to become one of the country's most effective humanitarian assistance organizations. Its work earns broad recognition from independent charity rating agencies, including a 100% fundraising efficiency rating from Forbes, a top ranking by Charity Navigator, and a spot in Fast Company’s list of “the world’s most innovative nonprofits.”  Direct Relief’s impact throughout the world is the result of its dedicated and compassionate people, each of whom plays a critical role in advancing the organization's mission. 

Summary:

The Quality Specialist will support the day-to-day execution of the organization’s quality program through discrepancy investigations, CAPA administration and management, and continuous improvement initiatives. The Qualitiy Specialist works cross-functionally to identify root causes, implement corrective actions, and improve business processes.  

Responsibilities:

Discrepancy Investigations

• Lead discrepancy and quality event investigations
• Facilitate root cause analysis activities using appropriate quality tools
• Develop and track Corrective and Preventive Actions (CAPAs)
• Verify completion and effectiveness of CAPAs
• Support data review and trend analysis

Quality Management System (QMS)

• Support the implementation of new QMS modules and workflows
• Support the development of quality-related procedures and training resources
• Participate in cross-functional document and training updates, as they relate to investigation findings and CAPAs

Continuous Improvement

• Collaborate with teams to identify and support continuous improvement initiatives, including process development.
• Support the development and management of supplier qualification procedures in collaboration with cross-functional teams
• Participate in supplier and other quality audits 

Qualifications:

• Bachelor’s degree or equivalent combination of education and experience
• 3+ years of experience in Quality or related discipline
• Experience with investigations, CAPAs, and Quality Management Systems (MasterControl preferred)
• Experience with root cause analysis methodologies and continuous improvement tools is preferred
• Good working business process knowledge of supply chain operations, including procurement, warehouse operations, and order fulfillment 

Skills:

• Proficient in working with Microsoft Word, Excel, Visio, and PowerPoint
• Knowledge of FDA-regulated environments, GDP, and quality systems
• Strong verbal and written communication skills
• Strong analytical and problem-solving skills
• Collaborative working style with a commitment to high standards of professionalism and integrity

Must have US work authorization to be considered for role.  Sponsorship not available.