Corporate Quality and Clinical Auditor

Job Description

As a Corporate Quality and Clinical Auditor, you will support company-wide clinical quality and compliance programs through execution of risk-based audits, audit system oversight, regulatory intelligence, and inspection readiness. This role evaluates clinical quality systems, supports global regulatory compliance and provides expert leadership across internal and external audit activities. This role develops and maintains audit electronic audit systems, analyzes data for reporting, and supports risk-based and special audits, including those related to new acquisitions and transfers.
The auditor evaluates and monitors corrective actions, supports FDA inspections and external audits, and facilitates inspection-readiness training.

Essential Duties and Responsibilities

• Manage key components of the compliance audit program under the Community of Practice for Quality Audits to ensure process and product conformance per company and regulatory requirements.
• Evaluate, maintain, and analyze compliance audit metrics to ensure internal and external audit results are properly tracked across Hologic locations.
• Support the Director of Internal Audit in the annual Compliance Audit report for the Executive team.
• Develop and manage special audit tasks and support the risk-based approach for clinical audits.
• Evaluate and monitor corrective actions from clinical audits; coordinate joint audits, special compliance gap assessments, and FDA inspection readiness training.
• Support FDA and external audit activities as assigned.
• Identify compliance issues, evaluate risks associated with clinical activities, and drive internal manufacturing compliance improvements to reduce compliance risk.
• Support clinical audit activities for recently acquired companies or products, maintain and update the electronic audit module, assess external regulatory trends, and provide strategic updates on clinical compliance performance.

Supervisory Responsibilities

• None

Qualifications

Education

• B.S. in Engineering, Science, or related field. (Strongly recommended focus in Electrical or Electronic engineering, Chemist, Microbiology or Science)
• Active Certification as IRCA, RABQSA, ASQ CMDA (preferred), ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead Auditor Qualification by a recognized organization
• Minimum of 8 years of experience in one or more of the following areas: Quality Engineering, R&D, Compliance, Quality Operations with focus in installation, servicing, refurbishing activities, chemical compliance, clinical studies, current Good Clinical Practices
• Minimum of 5 years’ experience as a Clinical or Lead Auditor in a regulated industry

Experience & Skills

Regulatory and Technical Knowledge Required

Documented courses with assessments are preferred

• ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good clinical practice
• ISO 20916:2019 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects
• ISO 14971:2019 – Medical devices – Application of risk management to medical devices
• ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
• ISO/IEC 27001 - Information security for clinical data systems
• Regulation (EU) 2017/745 – Medical devices (MDR)
• Regulation (EU) 2017/746 – In vitro diagnostic medical devices (IVDR)
• UK Medical Devices Regulations 2002 (as amended)
• US FDA 21 CFR Parts 11, 50, 54, 56, 812
• US FDA 21 CFR Parts 800–898 – Medical Device Regulations (incl. 21 CFR 820 – QMSR)
• US FDA Bioresearch Monitoring Program (BIMO)
• Canada: SOR/98-282 – Medical Devices Regulations
• Australia: Therapeutic Goods (Medical Devices) Regulations 2002
• Japan: Pharmaceuticals and Medical Devices Act (PMD Act)
• Brazil: Law No. 6.360/1976 and associated ANVISA medical device RDCs
• European Union: Regulation (EU) 2017/745 – Medical Devices (MDR); Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Devices (IVDR)
• Good Clinical Practices and Good Laboratory Practices
• Statistical techniques and sampling plans
• Process, equipment and design validation, test method validation
• Software validation requirements (product and non-product)
• Expert skills using SharePoint, Teams, PowerPoint and Excel

Highly desired

• Additional working knowledge of European Standards and Regulations
• Experience in other global regulatory requirements e.g. Korea, China, Swiss, UK etc.
• Working knowledge of Artificial Intelligence regulations and standards
• Strong project management and failure investigation/root cause analysis skills
• Current ASQ certifications, e.g. CMDA, CQA and CQE
• Excellent written and verbal communication skills
• Strong interpersonal and cross-functional leadership skills
• Multilingual e.g. English and Spanish, German, French, or Chinese

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.