Quality Specialist jobs in United States
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Direct Relief · 9 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.

AssociationCharityHealth CareHumanitarianMedicalNon Profit
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Hiring Manager
Julie Lofing, CDR
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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

Quality Management SystemsData analysisElectronic quality systemsLean principlesSix SigmaSAPISO standardsMicrosoft OfficeTraining programsAnalytical skillsProblem-solving skillsCommunication skillsDetail oriented

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

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Direct Relief is a humanitarian medical aid organization.

Funding

Current Stage
Growth Stage

Leadership Team

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Amy Weaver
Chief Executive Officer
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Craig Redmond
Chief Operating Officer
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Company data provided by crunchbase