Quality Assurance​/Performance Improvement ISO Specialist; On-Site

Excluded States

The following states/districts are excluded from this job ad: AK, CA, CO, CT, DC, HI, LA, MA, MN, MO, NE, NV, NH, NJ, NM, NY, ND, OR, PR, RI, VT, WA, WY.

Future Need - Actively Interviewing

Join us in supporting the Joint Pathology Center as a Quality Assurance / Performance Improvement ISO Specialist. In this role, you will lead ISO 15189 compliance efforts, support CAP accreditation activities, and drive continuous improvement initiatives in a mission-focused federal healthcare environment.

Joint Pathology Center, 606 Stephen Sitter Ave, Silver Spring, MD 20910.

The role provides ISO program management, compliance oversight, accreditation support, and quality improvement services in support of Joint Pathology Center (JPC) operations.

10 years of quality assurance, performance improvement, and ISO experience.

Bachelor's degree in Information Technology, Business Administration, Engineering, or related field.

• 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 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.

• Align the ISO program with applicable standards and best practices, including ISO 15189.
• Provide ISO training and guidance for departments and staff.
• Conduct periodic reviews of the ISO program to ensure continued relevance and compliance.
• Lead CAP and ISO assessments, identify gaps, and implement corrective actions.
• Manage nonconformance tracking and corrective action programs.
• Develop metrics and reports to evaluate compliance effectiveness.
• Conduct trend analysis of nonconformities to inform process improvements.
• Plan, conduct, and document internal audits.
• Recommend and track corrective actions.
• Conduct risk assessments and develop mitigation strategies.
• Communicate compliance risks and audit outcomes to leadership.
• Serve as a subject matter expert on regulatory and ISO requirements.
• Write, update, and maintain procedures, policies, and controlled documents.
• Establish and maintain document control systems.
• Train staff on documentation and compliance practices.
• Support validation and documentation of new LDTs.
• Monitor regulatory changes and update procedures accordingly.
• Advise JPC leadership on compliance risks and ISO strategy.
• Promote Lean and Six Sigma principles.
• Support preparation for external audits and inspections.
• Maintain compliance resource repositories and reporting tools.

The annual projected pay range for this position is $108,142 - $127,631. Consideration is based on qualifications, experience, job responsibilities, and geographic location.

Benefits include:

• Medical, dental, vision, and prescription drug coverage.
• Life insurance, short‑term and long‑term disability.
• Supplemental coverages:
  Accident, Critical Illness, Hospital.
• Additional life insurance for dependents.
• 401(k) plan options.

All qualified applicants will receive consideration for employment without regard to any status protected by applicable federal, state, or local law.