Global Clinical Quality Auditor

DIRECT SALES, US; United States; On-site; USD 138,000 - 230,000; Full time

Job summary

Hologic, Inc. seeks a Corporate Quality and Clinical Auditor to support company-wide clinical quality and compliance programs through audits, regulatory intelligence, and inspection readiness.

This role leads risk-based audits, oversees electronic audit systems, analyzes data for reporting, and supports special audits including acquisitions. The position requires extensive experience in quality engineering, clinical audits, and regulatory requirements, with responsibilities to monitor corrective

Qualifications

• 8+ years of experience in Quality Engineering, R&D, Compliance or Quality Operations in regulated settings.
• 5+ years as a Clinical or Lead Auditor in a regulated industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Parts 11-56, MDR/IVDR, GCP and related standards.
• Experience with audit systems, risk-based auditing and regulatory intelligence.

Responsibilities

• Manage key components of the compliance audit program to ensure conformance with requirements.
• Evaluate, maintain, and analyze compliance audit metrics across locations.
• Support the Director of Internal Audit in annual Compliance Audit reporting.
• Develop and manage special audit tasks and risk-based clinical audits.
• Evaluate corrective actions from audits; coordinate joint audits and FDA readiness training.
• Support FDA and external audit activities as assigned.
• Identify compliance issues and drive improvements to reduce risk.
• Support audits for recently acquired entities and update electronic audit modules.

Skills

Quality Auditing

Regulatory Knowledge

FDA Regulations

Project Management

Software Validation

Education

B.S. in Engineering/Science

Lead Auditor Certification (IRCA/RABQSA/ASQ CMDA)

ISO 13485 Lead Auditor

Tools

SharePoint

Teams

PowerPoint

Excel

Job description

Hologic, Inc. seeks a Corporate Quality and Clinical Auditor to support company-wide clinical quality and compliance programs through audits, regulatory intelligence, and inspection readiness.

This role leads risk-based audits, oversees electronic audit systems, analyzes data for reporting, and supports special audits including acquisitions. The position requires extensive experience in quality engineering, clinical audits, and regulatory requirements, with responsibilities to monitor corrective