Corporate Quality Principal Auditor
Location: South Korea, Japan, Taiwan or Dubai
At Hologic, we are committed to enabling healthier lives everywhere, every day, and robust, forward looking compliance is essential to that mission.
We are looking for a Corporate Quality Principal Auditor to play a strategic role in supporting and strengthening our global Quality Audit program. You will help ensure conformance with regulatory and company requirements across the enterprise, while driving continuous improvement and reducing compliance risk.
This is a high-impact opportunity for an experienced audit professional who thrives in a regulated environment, enjoys working with data and systems, and can confidently partner with teams across global sites and functions.
What To Expect:
In this role, you will:
- Support key elements of Hologic’s global Quality Audit program.
- Develop, maintain, and improve audit metrics and processes
- Analyze data, and prepare executive-level and detailed audit reports
- Plan, lead and perform risk-based corporate compliance audits, special audits, and gap assessments.
- Support audits related to new acquisitions, product or process transfers, suppliers, and complex manufacturing processes.
- Identify compliance risks and drive manufacturing and Quality Management System improvements.
- Support FDA inspections and external audits, including front-room and back-room activities when needed
- Act as an audit subject matter expert and coach, guiding teams on audit expectations, execution, and documentation
- Partner cross-functionally with Manufacturing, Quality Engineering, R&D, Compliance, Quality Operations, and other teams.
- Use regulatory trends, audit outcomes, and internal performance data to support risk-based planning and continuous improvement.
What We Expect:
- Bachelor’s degree in Engineering, Science, or a related technical discipline.
- Minimum 5 years’ experience as a Principal or Lead Auditor in a regulated industry with current certifications.
- Minimum 3 years’ experience in Manufacturing, Quality Engineering, R&D, Compliance, Quality Operations, servicing, refurbishing, chemical compliance, clinical studies or equivalent.
- Strong knowledge of applicable quality and regulatory requirements, including 21 CFR 820 / QMSR, ISO 13485, MDSAP, FDA regulations, ISO 14971, ISO 19011, ISO 14155, EU MDR, EU IVDR, REACH, RoHS, and Conflict Minerals.
- Proven experience planning, leading, and supporting internal, external, corporate, site, FDA, supplier, acquisition, transfer, and risk-based audits.
- Ability to assess compliance risk, evaluate audit findings, monitor corrective actions, and support effective CAPA, root cause analysis, and systemic quality improvements.
- Experience with validation activities, including process, equipment, design, test method, and software validation.
- Strong data analysis and reporting skills, including audit metrics, trend analysis, executive reporting, and annual Compliance Audit reports.
- Experience maintaining electronic audit systems or eQMS audit functionality.
- Advanced proficiency with SharePoint, Teams, PowerPoint, Word and Excel.
- Strong project management skills, with the ability to coordinate multi-site and cross-functional audit activities.
- Experience supporting FDA inspection readiness, including front-room and back-room activities.
- Excellent written and verbal communication skills, with the ability to coach, influence, and act as an audit subject matter expert.
- Proactive, organized, analytical, collaborative, and committed to continuous improvement.
- Additional global regulatory knowledge, AI-related healthcare regulation awareness, GCP/GLP understanding, multilingual capability
- Active Lead Auditor certification from a recognized accreditation company is required.
Why Join Hologic?
We are committed to making Hologic the destination for top talent. From the moment you join, we will support you with the tools, training, and knowledge you need to succeed. You will also have access to continued development and training throughout your career.
At Hologic, your work will help strengthen quality systems, support regulatory confidence, and contribute to our mission of enabling healthier lives everywhere, every day. Apply now!
#LI-RH1
Bachelor's degree in engineering, science, or related technical discipline; 5+ years as Principal/Lead Auditor in regulated industry with active Lead Auditor certification; 3+ years in manufacturing, quality, R&D, compliance, or equivalent; strong knowledge of FDA, ISO, MDSAP, EU MDR/IVDR, REACH, RoHS, Conflict Minerals; advanced SharePoint, Teams, PowerPoint, Word, Excel.
Key Responsibilities
- planning audits
- analyzing data
- supporting inspections
Skills & Tools
Microsoft SharePoint, Microsoft Teams, Microsoft PowerPoint, Microsoft Word, Microsoft Excel
Job Details
- Category: Quality Assurance
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Korea or Japan or Taiwan or Dubai
- Languages: English
About Hologic
A medical technology company committed to enabling healthier lives everywhere, every day. — Industry: Healthcare