Manager, Compliance Audit Engineering

As a Manager in Compliance Audit Engineering at Hologic, you'll be tasked with managing the Corporate and Internal Compliance Audit risk assessment process. Your responsibilities will include developing training materials for auditors, leading audits for compliance with various regulations, evaluating corrective actions from audits, and facilitating FDA readiness training. Additionally, you will contribute to enhancing our electronic audit system and address product failures through coordinated multi-site QA audit reviews.

Candidates for the Manager Compliance Audit Engineering position at Hologic should possess a B.S. in Engineering or a related field. It's essential to have an active certification as a Lead Auditor, such as IRCA or ISO 13485:2016, along with 5-7 years of relevant experience in manufacturing, quality engineering, or compliance specifically within the medical devices sector. Strong knowledge in quality systems and risk analysis is critical for success.

The Compliance Audit Engineering Manager at Hologic must have in-depth regulatory and technical knowledge, including QMS regulations like ISO 13485 and 21 CFR 820, as well as risk management standards such as ISO 14971. Familiarity with audit approaches like ISO 19011 and technical documentation requirements for EU MDR and IVDR will also play a crucial role in your day-to-day responsibilities.

Yes, the Manager of Compliance Audit Engineering position at Hologic involves approximately 30-40% global travel. This aspect of the role is essential as you'll be engaging with various teams and stakeholders to ensure compliance and audit readiness in diverse settings.

Hologic is committed to professional development, offering comprehensive training when you join and ongoing training throughout your career. This environment is designed to help you succeed and grow, with the resources you need to excel as a Manager in Compliance Audit Engineering, including opportunities for further certification and skill enhancement.

In preparing to answer this question, focus on your ability to understand various compliance frameworks, like ISO and FDA regulations. Highlight your experience in navigating these requirements, emphasizing your systematic approach to audit processes and how you stay updated on regulatory changes.

Use specific examples from your past roles where you've conducted risk assessments. Detail the methodologies you've employed, how you identified risks, and the subsequent actions taken to mitigate those risks. It's vital to demonstrate a hands-on approach and understanding of risk management principles.

When discussing this, outline the key components you believe are essential for an effective training program. Consider discussing your methods for engaging participants, ensuring understanding, and providing hands-on training or materials that support compliance with FDA requirements.

Prepare to discuss a specific audit, focusing on the challenges faced and how you addressed them. Highlight the strategies you implemented, the collaboration with team members, and any improvements that arose from your findings, showing your ability to turn challenges into successful outcomes.

Explain your approach by describing how you prioritize corrective actions based on severity and potential impact on compliance. Provide an example of a time when you successfully implemented a corrective action plan and aided continuous improvement.

This is a chance to showcase your innovative side. Discuss any specific changes you've made to streamline processes, enhance audit efficiency, or improve compliance outcomes based on your insights and experience. Highlight metrics impacted positively by your initiatives.

Discuss your experience in developing training programs and materials. Emphasize the importance of continuous education and how you assess the needs of auditors to tailor training that keeps them informed of changes in compliance expectations.

Reflect on your experience working with cross-functional teams. Describe how collaboration leads to enhanced compliance and audit outcomes, and provide examples of successful teamwork and communication strategies that have made a difference.

Identify qualities such as strong analytical skills, attention to detail, communication abilities, and leadership. Support your reasoning with examples of how these qualities have played a role in your success in previous roles or how you would apply them at Hologic.

Emphasize the importance of continuous learning and staying informed. Talk about resources you utilize to keep updated, such as seminars, webinars, professional groups, or industry publications. This showcases your commitment to excellence and adaptation.