Senior Quality Audit & CAPA Leader — 130+ Sites

Loyal Source

United States

Remote

USD 120,000 - 160,000

Full time

5 days ago
Be an early applicant
Application generator

Get a reply from this recruiter — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

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

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

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Senior CAPA & Quality Systems Engineer
Senior CAPA & Quality Systems Engineer

Real Staffing Group • Virginia (MN)

On-site
USD 140,000 - 170,000
Health insurance
Retirement savings plan
Life and disability insurance
+1
Senior Quality & Compliance Manager – CMMI/ISO Audits
Senior Quality & Compliance Manager – CMMI/ISO Audits

Systems Planning & Analysis • Alexandria (VA)

On-site
USD 150,000 - 180,000
Health insurance
Flexible spending accounts
Health savings accounts
+3
Quality Systems Auditor & CAPA Lead
Quality Systems Auditor & CAPA Lead

Oxford Global Resources • Irvine (CA)

On-site
USD 81,000 - 106,000
Supplemental medical
Dental
Vision
+5
Senior Quality Engineer - QMS & CAPA Leader
Senior Quality Engineer - QMS & CAPA Leader

Access Vascular, Inc. • Billerica (MA)

On-site
USD 93,000 - 160,000
Quality Audit & CAPA Manager
Quality Audit & CAPA Manager

Loyal Source • United States

Remote
USD 120,000 - 160,000
Quality Assurance Leader: Audits, CAPA & Compliance
Quality Assurance Leader: Audits, CAPA & Compliance

Meso Scale Diagnostics LLC • Rockville (MD)

On-site
USD 117,000 - 178,000
Medical coverage
Dental coverage
Vision coverage
+7
Quality Assurance Leader - ISO/FDA Audits & CAPA
Quality Assurance Leader - ISO/FDA Audits & CAPA

Meso Scale Diagnostics, LLC. • Rockville (MD)

On-site
USD 117,000 - 178,000
Medical, dental, vision coverage
401(k) plan with company matching
Paid vacation
+9
Senior Quality Manager - ISO 9001/13485 | CAPA & Lean
Senior Quality Manager - ISO 9001/13485 | CAPA & Lean

Randstad USA • Union City (CA)

On-site
USD 135,000 - 155,000
Quality Engineer - CAPA & Audit Lead (Medical Devices)
Quality Engineer - CAPA & Audit Lead (Medical Devices)

Siemens Healthineers AG • Cary (NC), Northern (KY)

Hybrid
USD 89,000 - 123,000
Medical insurance
Dental insurance
Vision insurance
+6
Senior Quality Leader – Multi‑Site ISO & CAPA Expert
Senior Quality Leader – Multi‑Site ISO & CAPA Expert

Galvion LTD • Town of Vermont (WI)

On-site
USD 90,000 - 130,000