Quality Assurance / Performance Improvement ISO Specialist (ISO 15189)

TL;DR

Quality Assurance / Performance Improvement ISO Specialist (ISO 15189): Leading ISO 15189 compliance efforts and CAP accreditation activities within a federal healthcare environment with an accent on program management, compliance oversight, and continuous improvement. Focus on identifying gaps, implementing corrective actions, and conducting internal audits to ensure regulatory adherence.

Location: On-Site in Silver Spring, MD, USA. U.S. Citizenship required.

Salary: $108,142 - $127,631 per year

Company

hirify.global is a certified service-disabled veteran-owned small business with 26 years of experience delivering quality IT systems and programs for federal agencies.

What you will do

• Align the ISO program with applicable standards and best practices, specifically ISO 15189.
• Lead CAP and ISO assessments, identify gaps, and implement corrective actions.
• Manage nonconformance tracking and develop metrics to evaluate compliance effectiveness.
• Plan, conduct, and document internal audits and risk assessments.
• Write, update, and maintain procedures, policies, and controlled documents.
• Advise leadership on compliance risks and ISO strategy.

Requirements

• 10 years of experience in quality assurance, performance improvement, and ISO.
• Active DoD Secret Clearance; ability to obtain DoD Top Secret Clearance.
• U.S. Citizenship is required.
• Bachelor's degree in IT, Business Administration, Engineering, or a related field.
• Expertise in ISO 15189 and CAP accreditation.
• Knowledge of Lean and Six Sigma principles and FDA regulations for LDT compliance.

Culture & Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage for employees and families.
• Company-paid life, short-term, and long-term disability insurance.
• 401k retirement plan with multiple options.
• Supplemental coverages including Accident, Critical Illness, and Hospital insurance.