Quality Assurance / Performance Improvement ISO Specialist (On-Site)

Oxley Enterprises®, Inc. • Silver Spring, MD

1d • $108,142 - $127,631 • Onsite

About The Position

Join us in supporting the Joint Pathology Center as a Quality Assurance / Performance Improvement ISO Specialist. In this role, you'll lead ISO 15189 compliance efforts, support CAP accreditation activities, and drive continuous improvement initiatives in a mission-focused federal healthcare environment. The Quality Assurance / Performance Improvement (QA/PI) International Organization for Standardization (ISO) Specialist provides ISO program management, compliance oversight, accreditation support, and quality improvement services in support of Joint Pathology Center (JPC) operations.

Requirements

• 10 years of quality assurance, performance improvement, and ISO experience
• Above average experience developing, implementing, and maintaining ISO-compliant policies and procedures
• Above average experience providing ISO training and conducting reviews
• Above average experience leading College of American Pathologists (CAP) and ISO assessments
• Experience identifying gaps and implementing corrective actions
• Knowledge of Laboratory Developed Testing (LDT) compliance with Food and Drug Administration (FDA) regulations and accreditation standards
• Knowledge of CAP accreditation
• Knowledge of Lean and Six Sigma principles
• Experience developing metrics and reports
• Experience with ISO 15189 standards
• Experience supporting a federal agency
• Excellent written and verbal communication skills
• Active DoD Secret Clearance
• Ability to obtain DoD Top Secret Clearance as needed
• U.S. Citizenship

Responsibilities

• Aligns the ISO program with applicable standards and best practices, including ISO 15189
• Provides ISO training and guidance for departments and staff
• Conducts periodic reviews of the ISO program to ensure continued relevance and compliance
• Leads CAP and ISO assessments, identifies gaps, and implements corrective actions
• Manages nonconformance tracking and corrective action programs
• Develops metrics and reports to evaluate compliance effectiveness
• Conducts trend analysis of nonconformities to inform process improvements
• Plans, conducts, and documents internal audits
• Recommends and tracks corrective actions
• Conducts risk assessments and develops mitigation strategies
• Communicates compliance risks and audit outcomes to leadership
• Serves as a subject matter expert on regulatory and ISO requirements
• Writes, updates, and maintains procedures, policies, and controlled documents
• Establishes and maintains document control systems
• Trains staff on documentation and compliance practices
• Supports validation and documentation of new LDTs
• Monitors regulatory changes and updates procedures accordingly
• Advises JPC leadership on compliance risks and ISO strategy
• Promotes Lean and Six Sigma principles
• Supports preparation for external audits and inspections
• Maintains compliance resource repositories and reporting tools

Benefits

• Medical, dental, vision and prescription drug coverage for you and your family.
• Life Insurance, short-term disability and long-term disability paid for by the Company.
• Supplemental coverages including Accident, Critical Illness, and Hospital.
• Additional Life insurance coverage for you and your dependents.
• 401k plan with various options to select based on your retirement goals.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior