Description
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'll lead ISO 15189 compliance efforts, support CAP accreditation activities, and drive continuous improvement initiatives in a mission-focused federal healthcare environment.
Location: Joint Pathology Center, 606 Stephen Sitter Ave, Silver Spring, MD 20910
Position Description: 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.
Tasks/activities include, but are not limited to:
- 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
Compensation & Benefits: The annual projected pay range for this position is $108,142 - $127,631 with consideration being given to various factors including but not limited to qualifications, experience, job responsibilities, and geographic location.
Oxley Enterprises, Inc. offers a full array of benefits including:
- 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.
Oxley Enterprises®, Inc. is a certified service-disabled veteran-owned (SDVOSB), veteran-owned (VOSB), and woman-owned small business (WOSB) that has 26 years of experience building and delivering quality IT systems and programs. Oxley is ranked in the INC 5000 7 times (2016, 2017, 2018, 2021, 2023, 2024, 2025). Oxley is a 2019 - 2025 Department of Labor HIRE Vets Medallion Award Winner. Oxley is Virginia Values Veterans certified.
All qualified applicants will receive consideration for employment without regard to any status protected by applicable federal, state, or local law.
If you require a reasonable accommodation to apply for a position at Oxley Enterprises, Inc., please send an email to our Human Resources Department at: careers@oxleyenterprises.com with the following information:
Subject Line: Accommodation Request
Provide a description of your accommodation request
Include your contact information: Full name, Email address, Best number to reach you (optional)
We participate in the E-Verify program. http://www.dhs.gov/E-Verify
Requirements
Minimum/General Experience: 10 years of quality assurance, performance improvement, and ISO experience
Minimum Education: Bachelors Degree in information technology, business administration, engineering or related field
Essential Skills/Qualifications:
- 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
General Physical Requirements needed to perform the essential functions of this job may vary based on the location of the assignment.
- Assignment Location - Joint Pathology Center, 606 Stephen Sitter Ave, Silver Spring, MD 20910
- Sedentary Work - Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
- Typing, communicating, repetitive motions.
- Close visual acuity to prepare and analyze data, view computer monitors and read. May need to view presentation screens and other visual aids in a virtual setting.
- Inside environmental conditions with protection from outside elements.
Security: Active DoD Secret Clearance; Ability to obtain DoD Top Secret Clearance as needed
- U.S. Citizenship
DoD Clearance Consists of a review of up to but not limited to:
- Covers 10 year period and in some instances lifetime events
- OPM Security Investigations Index (SII)
- DOD Defense Central Investigations Index (DCII)
- National Agency Check (NAC) records
- FBI name check
- FBI fingerprint check
- Credit report check
- A check of local law enforcement agencies with jurisdiction over the areas where the applicant has lived, worked, or attended school
- Education check- Attendance and Degrees
- Employment verification -may include interviews of supervisors and/or co-workers
- Corroboration of unemployment
- May include reference interviews
- May include interviews of the individual, former spouse (s)
- Confirmation of all residences
- Verification of public record information
