Manager, Compliance Audit Engineering

Job Summary: 

This individual will work under the direction of the Director of Compliance and will manage several technical aspects of the Center of Excellence for QARA Audits. The role will manage the overall Corporate and Internal Compliance Audit risk assessment process for the company, the technical audit strategy and will be part of the Corporate Compliance audit team.

Essential Duties and Responsibilities:

• Maintain and enhance the Risk Process approach in the audit system to support company goals.
• Develop technical audit training and materials for auditors, including product/process/software validations, statistical techniques, risk management, root cause analysis, and technical documentation.
• Lead technical documentation audits for compliance with EU MDR, EU IVDR, and US FDA regulations.
• Establish compliance audit metrics and coordinate cross-functional compliance programs.
• Evaluate and monitor corrective actions from corporate audits.
• Facilitate FDA readiness training and support external regulatory audits.
• Identify compliance improvement solutions and evaluate technical risks associated with transfers and acquisitions.
• Participate in due diligence and integration activities for acquisitions.
• Understand complex manufacturing processes to develop tools for continuous improvement.
• Contribute to the improvement of the electronic audit system.
• Address complex product failures and facilitate multi-site QA audit reviews.

Qualifications:

• B.S. in Engineering or related field (Physics, Electrical, Mechanical, or Statistics focus recommended).
• Active certification as IRCA, RABQSA, CMDA, CQA, ISO 13485:2016 Lead Auditor, EU MDR or EU IVDR Auditor.
• 5-7 years in Manufacturing, Quality Engineering, R&D, Compliance, Quality Systems, or Regulatory Affairs in medical devices.
• 5-7 years as a Lead Auditor or technical auditor.
• 6-9 years in gap assessment, risk analysis, and compliance activities in quality systems for medical devices.
• Strong knowledge in quality engineering, electrical medical devices, sterilization, statistical techniques, or software validation.
• This role involves working in a regular office environment with 30-40% global travel.

Regulatory and Technical Knowledge:

• QMS Regulations: 21CFR 820, ISO 13485, TG(MD)R 2002, RDC16, MHLW MO 169.
• Risk Management: ISO 14971.
• Audit Approach: ISO 19011, MDSAP.
• Technical Documentation: EU MDR 17/745, IVDR 17/746.
• Safety Electronics: IEC 60601.
• Metrology and Labs: ISO 17025.
• Software development, codification, validation.
• Statistical Techniques: Sampling plans, linear models, design of experiments, regression analysis, meta-analysis, measurement system analysis.

Highly desired:

• Bilingual (i.e. Spanish, German, French, 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 $139,700 to $179,400 and is bonus eligible.  Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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 Department. In 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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