Global Clinical Quality & Compliance Auditor

Hologic, Inc.; Natick (MA); On-site; USD 138,000 - 230,000; Full time

Job summary

Hologic, Inc. seeks a Corporate Quality and Clinical Auditor to advance company‑wide clinical quality programs through risk‑based audits, audit systems, regulatory intelligence, and inspection readiness.

You will lead audits, monitor corrective actions, and support FDA inspections with data‑driven insights. You will develop and maintain electronic audit modules, analyze metrics, and drive improvements across locations.

Qualifications

• BS in engineering, science, or related field with relevant regulatory focus.
• Preferred certifications in medical device auditing and quality management systems.
• Minimum years of experience in quality, compliance, or clinical audits in regulated industries.

Responsibilities

• Lead and oversee the corporate quality and clinical audit program.
• Support FDA inspections and external audits; manage audit metrics and reporting.
• Develop and maintain audit systems; drive corrective actions and continuous improvement.
• Coordinate risk-based and special audits, including post-acquisition activities.

Skills

Auditing

Regulatory knowledge

Project management

Communication skills

Multilingual

Education

B.S. in Engineering, Science, or related field

IRCA / RABQSA / ASQ CMDA / ISO 13485 Lead Auditor certifications

EU MDR or EU IVDR Lead Auditor qualifications

Tools

SharePoint

Teams

PowerPoint

Excel

Job description

Hologic, Inc. seeks a Corporate Quality and Clinical Auditor to advance company‑wide clinical quality programs through risk‑based audits, audit systems, regulatory intelligence, and inspection readiness.

You will lead audits, monitor corrective actions, and support FDA inspections with data‑driven insights. You will develop and maintain electronic audit modules, analyze metrics, and drive improvements across locations.