Quality Specialist

Socket.dev; Santa Barbara (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Direct Relief in Santa Barbara, CA, seeks a Quality Specialist to support the Quality Management System (QMS). You will facilitate training programs, handle discrepancy investigations, and manage document control workflows while ensuring compliance and user-friendly quality processes.

You will work cross-functionally to maintain metrics, drive continuous improvement, and support CAPA activities within an FDA-regulated environment.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 3–5 years of experience in Quality Assurance, Quality Systems, Compliance, Training, or related field.
• Experience with a Quality Management System, including document control and training management.
• Knowledge of Supply Chain, Warehousing, Distribution, and Logistics in an FDA-regulated industry preferred (GDP).
• Understanding of GDP and quality system requirements in a regulated environment.
• Experience coordinating training programs and maintaining training records.

Responsibilities

• Support day-to-day administration and maintenance of the QMS, ensuring records and workflows are current and compliant.
• Assist with implementation, testing, validation, and continuous improvement of automated workflows in MasterControl.
• Provide user support and troubleshooting for QMS processes.
• Generate and analyze quality metrics and dashboards for management reviews and continuous improvement.
• Investigate discrepancies, perform root cause analysis, and facilitate timely resolution of quality issues.
• Support CAPA activities and change management, maintaining related records.

Job description

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 supports the execution and continuous improvement of the organization's Quality Management System (QMS). This position is responsible for facilitating quality processes including training administration, discrepancy investigations, document control workflows, and quality metrics reporting. The Quality Specialist works cross-functionally to ensure quality requirements are effectively implemented, employees are properly trained on applicable procedures, and quality systems remain compliant, efficient, and user-friendly.

Key Deliverables:

• QMSAdministrationand Maintenance
• Training ProgramManagement
• DiscrepancyInvestigation
• Change Control Support
• Document ControlWorkflows
• Quality Metrics & Reporting

Specific Duties/Responsibilities:

Quality Management System

• Support the day-to-day administration and maintenance of the Quality Management System (QMS), ensuring records, workflows, and documentation remain current and compliant.
• Assist with implementation, testing, validation, and continuous improvement of automated workflows and system enhancements in the electronic Quality Management System, MasterControl.
• Provide user support and troubleshooting for QMS processes and workflows, helping employees understand quality requirements and system functionality.
• Generate, maintain, and analyze quality metrics and dashboards to support management reviews and continuous improvement efforts.
• Collaborate with staff to investigate discrepancies, document findings, perform root cause analysis, and facilitate timely resolution of quality issues.
• Assist with the identification, implementation, and verification of corrective and preventive actions (CAPAs) to address root causes and prevent recurrence.

Training Program Management

• Support employee onboarding by facilitating quality systems training and ensuring new personnel complete required training assignments.
• Coordinate and facilitate employee training activities within the QMS, including assigning training, monitoring completion status, maintaining training records, and supporting training compliance requirements.
• Monitor training effectiveness through completion tracking, reporting, user feedback, and periodic review of training requirements.

Continuous Improvement

• Assist process owners in developing, revising, and maintaining quality-related procedures, work instructions, forms, training materials, and other controlled documents.
• Participate in cross-functional continuous improvement initiatives focused on improving business processes, operational effectiveness, and quality outcomes.
• Support change management activities by coordinating reviews, routing approvals, tracking implementation actions, and maintaining associated records.
• Promote quality awareness throughout the organization by serving as a resource for quality processes, documentation requirements, and training expectations.
• Other duties as assigned by management.

Skills, Attributes, and Qualifications:

Skills:

• ProficientinMicrosoftWord, Excel, Visio,SharePoint,Power Automate, and other business productivity tools.
• Experience with electronic Quality Management Systems (MasterControl preferred)
• Experiencecreating, administering, or facilitating employee training programs
• General knowledge of quality systems, ERP systems (SAP preferred), computer-based management systems, ISO standards,and application of FDA regulations for applicable products preferred.
• Strong data analysis, data management, and quantitative skills.
• Knowledge of Lean and Six Sigma principles and experience using those tools in improvement activities preferred.
• Strong written communication skills, including technical writing and procedure development.

Attributes:

• Collaborative and customer-service-oriented work style.

• Strong analytical andproblem-solvingskills.
• Detail-oriented with strong follow-through and accountability.
• Excellent verbal and written communication skills.
• Strong organizational skills with the ability to management multiple priorities and deadlines.
• Commitment to professionalism, integrity, and continuous improvement.
• Patient and supportive when guiding users through processes, systems, and training requirements.
• Ability to work independentlywith minimal supervision.

Qualifications:

• Bachelor’s degree or equivalent combination of education and experience.
• Minimum of 3-5 years of experience in Quality Assurance, Quality Systems, Compliance, Training, or a related field.
• Experience working within a Quality Management System, including document control, discrepancy investigations, and training management.
• Knowledge of and experience with Supply Chain Management, Warehousing, Distribution,and Logistics in an FDA-regulated industry required with a sound understanding of Good Distribution Practicesis preferred.
• Understanding of Good Documentation Practices (GDP) and quality system requirements in a regulated environment.
• Experience coordinating training programs, maintaining training records, and supporting compliance training activities is preferred.

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