Corporate Quality Principal Auditor

Hologic•Marlborough, MA

21h

About The Position

Hologic is committed to enabling healthier lives everywhere, every day—and robust, forward-looking compliance is essential to that mission. As a Corporate Quality Principal Auditor, you will play a critical role in managing key elements of the global Quality Audit program, ensuring conformance with regulatory and company requirements across the enterprise. Reporting to the Director of Internal Audit, you will develop and maintain audit metrics and electronic audit systems, analyze data for executive reporting, and support risk-based and special audits—including those related to new acquisitions, transfers, and complex manufacturing processes. You’ll act as a subject matter expert and audit coach, driving continuous compliance and quality improvements, supporting FDA and external audits, and facilitating inspection-readiness training across Hologic sites. If you’re an experienced lead auditor who thrives on data-driven oversight, cross-functional collaboration, and reducing compliance risk while supporting innovation in quality systems, this role is for you.

Requirements

QMS regulations: 21 CFR 820 (QMSR), ISO 13485, MDSAP country requirements.
US FDA regulations: 21 CFR Parts 801, 803, 806, 809, 862, 864, 866, Part 11, and other applicable FDA requirements.
Risk management: ISO 14971.
Audit standards and techniques: ISO 19011, MDSAP audit model and risk-based audit approaches.
Technical documentation and EU regulations: EU MDR 2017/745, IVDR 2017/746.
Chemical compliance: REACH, RoHS, Conflict Minerals.
Process, equipment, and design validation; test method validation.
Software validation (product and non-product).
Statistical techniques and sampling plans for audits and investigations.
Expert use of SharePoint, Teams, PowerPoint, and Excel for audit planning, tracking, collaboration, and reporting.
Experience maintaining and updating electronic audit modules or eQMS audit functionality.
Proven experience as a Principal or Lead Auditor in a regulated industry, managing complex compliance audits.
Ability to design, manage, and maintain audit metrics and electronic audit systems, ensuring accurate tracking of internal and external audit results across global locations.
Strong data analysis skills and experience preparing high-quality executive-level audit reports and annual Compliance Audit reports.
Skilled in evaluating, approving, and monitoring corrective actions from corporate compliance audits; coordinating joint audits and gap assessments.
Experience facilitating FDA inspection readiness training and supporting FDA and external audits (front-room and back-room).
Ability to identify issues and drive manufacturing and QMS compliance improvements to reduce regulatory risk.
Capable of evaluating risks associated with transfers, new acquisitions, and suppliers, and integrating findings into audit planning and follow-up.
Strong project management skills, including coordinating multi-site and cross-functional reviews of internal compliance audit performance.
Advanced root cause analysis/failure investigation capability to support effective CAPA and systemic improvements.
Excellent written and verbal communication skills for clear audit reports, guidance, and coaching.
Strong interpersonal and cross-functional leadership skills to act as an audit SME and coach across locations.
Minimum 5 years’ experience as a Principal or Lead Auditor in a regulated industry.
Minimum 3 years’ experience in one or more of the following: Manufacturing, Quality Engineering, R&D, Compliance, or Quality Operations (installation, servicing, refurbishing, chemical compliance, Clinical Studies).
Demonstrated experience supporting corporate and site internal audits, FDA inspections, and external audits.
B.S. in Engineering, Science, or related field: Electrical/Electronic Engineering, Chemistry, Microbiology, or similar science disciplines.
Active auditor certifications preferred, such as: IRCA, RABQSA, ASQ CMDA, ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead Auditor (from recognized organizations).

Nice To Haves

Additional working knowledge of European and other global regulatory requirements (e.g., Korea, China, Switzerland, UK).
Awareness of AI-related regulations and standards in healthcare/medical devices.
Understanding of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
Multilingual ability (e.g., English plus Spanish, German, French, or Chinese) is a significant plus.
Experience with audits related to acquisitions, transfers, or supplier oversight is highly valued.
Highly desired current ASQ certifications (e.g., CMDA, CQE).

Responsibilities

Managing key elements of the global Quality Audit program, ensuring conformance with regulatory and company requirements across the enterprise.
Developing and maintaining audit metrics and electronic audit systems.
Analyzing data for executive reporting.
Supporting risk-based and special audits—including those related to new acquisitions, transfers, and complex manufacturing processes.
Acting as a subject matter expert and audit coach.
Driving continuous compliance and quality improvements.
Supporting FDA and external audits.
Facilitating inspection-readiness training across Hologic sites.