Corporate Quality and Clinical Auditor

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.

• 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.

• None

• 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
• US FDA 21 CFR Parts 800898 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

• 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.

The annualized base salary range for this role is $138000-$230000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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