Quality Audit & CAPA Manager

Loyal Source; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Loyal Source is seeking a Quality Audit & CAPA Manager to provide strategic leadership for the enterprise site audit program. You will lead Quality Assurance Auditors, ensure audit independence, and drive CAPA and QMS improvements across 130+ sites.

The role supports expansion into medical healthcare and federally regulated operations, with remote work and frequent onsite assessments. Ideal candidates will have ISO 9001 knowledge, strong data trending skills, and experience in healthcare

Qualifications

• Bachelor's degree required; Master's preferred.
• Minimum 5 years in quality assurance, auditing, healthcare ops, or related fields.
• Minimum 2 years of supervisory or team leadership experience.
• Experience in healthcare, government contracting, or federally regulated environments preferred.

Responsibilities

• Lead, coach, and develop Quality Assurance Auditors across a broad program.
• Maintain audit independence and standardized methodologies.
• Coordinate auditor schedules across locations and conduct onsite oversight.
• Evaluate nonconformities and trigger CAPA with leadership input.
• Trend and report on 130+ site audit results to inform leadership.
• Align tools, SOPs, and training with ISO 9001 requirements.
• Support expansion into federal healthcare audits and regulatory environments.

Skills

Audit leadership

Quality assurance

Team leadership

ISO 9001 QMS

CAPA governance

Audit methodologies

Data trending

Root cause analysis

MS 365

EMR systems

Healthcare / federal contracting

Education

Bachelor's degree

Master's degree preferred

Tools

EMR systems

Audit tools

Microsoft 365

Job description

Summary

The Quality Audit & CAPA Manager provides strategic leadership, operational oversight, and performance management for the enterprise site audit program. This role leads Quality Assurance Auditors who conduct independent, standardized audits across VA Medical Disability Examination (MDE) clinics and, as the program expands, other healthcare operations.

The manager ensures audit independence and consistent methodology, trends results across 130+ sites, evaluates nonconformities, determines when corrective and preventive action (CAPA) is required, and strengthens the organization’s ISO 9001-aligned Quality Management System (QMS). As the functional leader for Quality Assurance Auditors, this role is accountable for audit governance, risk escalation, auditor competency, and continuous improvement of audit processes.

Job Classification

Salary

Duties and Functions

Audit Program Leadership & Oversight

• Lead, coach, and develop a team of Quality Assurance Auditors, with scalability as the audit program grows.
• Maintain audit independence and ensure consistent execution of standardized audit methodologies.
• Assign, prioritize, and coordinate auditor schedules across multiple locations.
• Conduct joint assessments and onsite oversight to calibrate auditor performance.
• Establish escalation criteria and provide day-to-day direction, escalation support, and decision-making for complex or high-risk audit issues.
• Ensure auditors complete in-briefs, onsite observations, exit briefings, and produce high-quality audit documentation.

Audit Analysis, Trending & Reporting

• Review, interpret, and trend 130+ site audit reports to identify systemic issues, risks, and improvement opportunities.
• Prepare executive-level summaries, dashboards, and presentations on audit outcomes and quality trends.
• Identify recurring challenges, operational gaps, and opportunities for efficiency.
• Provide strategic insight to leadership on audit observations that impact program performance and risk exposure.

ISO 9001 QMS Alignment & CAPA Oversight

• Lead nonconformity evaluation and ensure accurate classification and documentation.
• Determine when corrective and preventive action (CAPA) is required and partner with Quality leadership to initiate, monitor, and evaluate CAPA activities.
• Validate CAPA effectiveness through follow-up audits and documented evidence.
• Support internal audits of corporate processes, controls, and standards.
• Maintain audit tools, SOPs, checklists, and training materials aligned with ISO 9001 requirements.

Medical Healthcare and Federal Program Audit Capability

• Ensure auditors are trained and prepared to evaluate operational workflows, documentation standards, and compliance requirements in VA MDE clinics.
• Support expansion into medical healthcare audits, including federal contract compliance and operational readiness.
• Provide guidance on auditing non-ISO environments and federally regulated operations.

Collaboration & Stakeholder Engagement

• Serve as the primary audit program contact for Quality leadership and corporate quality SMEs (Documentation, Data, Generalist, Risk).
• Provide strategic insight into audit findings that impact quality, compliance, and customer satisfaction.
• Collaborate with program teams to ensure alignment between audit outcomes and operational expectations.

Team Development & Competency Management

• Coach auditors in audit techniques, evidence collection, report writing, and root cause analysis.
• Promote a culture of accountability, professionalism, and continuous improvement.
• Provide onboarding and ongoing training related to audit standards, QMS requirements, and operational expectations.
• Maintain auditor competency checklists and support skill-based deployment.

Education and Experience

• Bachelor's degree required; Master's degree preferred.
• Minimum 5 years of experience in quality assurance, auditing, healthcare operations, or a combination of these areas.
• Minimum 2 years of supervisory or team leadership experience.
• Experience in healthcare, government contracting, or federally regulated environments preferred.

Preferred Requirements

• ISO 9001 Internal Auditor or Lead Auditor training.
• Experience with VA MDE, healthcare operations, or similar federally regulated programs.
• Lean, Six Sigma, or process improvement certification.
• Experience developing audit checklists, inspection protocols, or compliance frameworks.

Knowledge/Skills/Abilities (KSA)

Knowledge: ISO 9001 QMS principles, nonconformity and corrective action processes, audit methodologies, and operational auditing in healthcare, federal contracting, and other regulated environments.

Skills: Multi-site audit data trending and systemic risk identification; evidence collection; root cause analysis; technical and audit report writing; stakeholder briefings and engagement; and proficient use of EMR systems, audit tools, and Microsoft 365.

Abilities: Exercise integrity, professionalism, sound judgment, analytical thinking, and attention to detail; communicate effectively with stakeholders; work independently in diverse onsite environments; manage multiple priorities; and travel extensively.

Supervisory Responsibilities

This position supervises a team of Quality Assurance Auditors who support audit coverage across 130+ sites.

Work Environment/Condition

Work is primarily remote, with required onsite assessments in office, clinic, or healthcare environments. The position requires 25% to 50% travel, including short-notice travel as operational needs require.

Physical Demands

The position requires the ability to travel using multiple transportation modes and to walk or stand for extended periods during onsite assessments, including in varying weather conditions.

Acknowledgement

Loyal Source provides healthcare and technology solutions designed to improve outcomes and support mission-critical operations. Guided by innovation and purpose, we help organizations achieve success across complex challenges worldwide. Loyal Source is a military friendly employer and proud partner of the Military Spouse Employment Partnership program.

Loyal Source uses AI-powered voice screening as part of our application process. After you apply, you will receive a brief qualification survey via text or email. Candidates who meet the position requirements will then be invited to complete a quick AI-powered voice assessment. This easy, no-scheduling-required process helps us and the candidate move the hiring process forward faster.

We are committed to providing equal employment opportunities to all applicants. If you have a disability or medical condition and need a reasonable accommodation to participate in this step of the hiring process, you may request an alternative method or accommodation at any time by contacting Human Resources at [e-mail].

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation by contacting HR at [e-mail]. If you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability, please select the accessibility menu to the (right or left) for more assistance. You can also request reasonable accommodations by contacting a telecommunications relay service by dialing 711 for direct access and assistance (tty).

This contractor and subcontractor abides by the requirements of 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a).
These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors.