Corporate Quality and Clinical Auditor

Hologic•Marlborough, MA

3d•$138,000 - $230,000

About The Position

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.

Requirements

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
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

Nice To Haves

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

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.