QA Compliance Lead: Audits & Inspections

Techtrueup; Greenville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Indotronix is seeking a QA Specialist III – Audits & Inspections to manage internal and external audits and regulatory inspections. You will drive compliance with 21 CFR Part 210/211, ISO standards, and ICH guidelines, coordinating cross-functional teams to sustain inspection readiness.

You will coordinate mock inspections, track KPIs, and manage deviations/CAPAs while maintaining documentation and traceability across the quality system.

Qualifications

• Education: Bachelor's degree in a scientific, engineering, or health-related field.
• Experience: At least 5 years in pharma/medical device quality.
• Experience: At least 8 years in quality, deviation management, or related areas.

Responsibilities

• External Audit Preparation & Execution: support scheduling, hosting, and responding to client audits.
• Inspection Readiness & Execution: support mock inspections and regulatory inspections with health authorities (FDA, EMA, ANVISA, MHRA).
• Governance: monitor audits/inspections, analyze data, report KPIs to leadership.
• Deviation & CAPA Management: track deviations and CAPAs, ensure timely responses.
• Effectiveness Checks: verify outcomes of audit CAPAs and prevention of recurrence.
• Communications: facilitate awareness and participation across teams.
• Documentation & Record retention: ensure critical docs are stored for audits.

Skills

Cross-functional collaboration

Communication

Problem solving

Documentation literacy

Attention to detail

Quality mindset

Education

Bachelor's degree in scientific/engineering/health field

Tools

Documentum

Veeva Vault

TrackWise

Job description

Indotronix is seeking a QA Specialist III – Audits & Inspections to manage internal and external audits and regulatory inspections. You will drive compliance with 21 CFR Part 210/211, ISO standards, and ICH guidelines, coordinating cross-functional teams to sustain inspection readiness.

You will coordinate mock inspections, track KPIs, and manage deviations/CAPAs while maintaining documentation and traceability across the quality system.