We anticipate the application window for this opening will close on - 20 Jun 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide.

At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision.

This position will be on-site 4+ day/week, based at one of the following Medtronic North America sites:

• Mounds View, MN

• Irvine, CA

• Tempe, AZ

• Lafayette, CO

• Danvers, MA

• Jacksonville, FL

Requires ~20% global travel per year.

Reporting to the VP of Quality Systems, the Sr Compliance Director - Core Quality Services functions as the global head of internal audit and compliance, leading a centralized global team supporting 100+ QMS entities, with responsibilities to:

1. Lead centralized Internal Audit function enterprise wide, including audit of all sites and audit of enterprise functions.

• Entity QMS (OU and Manufacturing sites).

• Device tracking audits.

• Functional Enterprise Audits. (excludes clinical and regional)

2. ​Lead Audit Inspection Readiness Assessment (AIRA) program for external inspection readiness across the enterprise.

• Strategy development in partnership with OU’s/ Platforms (Risk Burndown, defensibility, prioritization).

• Own Heat Map for enterprise sites and Operating Units (OU’s)

• High Risk Field Issue / Field Corrective Actions / For Cause Inspections.

• Understand Industry Insights.

• Regulator consultancy.

3. ​Process Owner, Manage Compliance process (Enterprise wide procedures for Internal and External Audit).

4. Data management and insights - connection of data (Internal audit data/ external audit data/ industry intelligence) for trends and potential for continuous improvement.

5. Individual Contributor on Critical / High risk Inspections.

6. Preparation and analysis of Metrics for: Global QMR (involving CEO) / Board of Directors meeting / External Sustainability Reporting.

• Prep and Communication of key data to CQO and Executive Leadership monthly.

7. Advocacy Presence: MDSAP Working Group, AdvaMed, Products councils.

8. Case For Quality Steering Committee member.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachelor’s degree in Engineering, Sciences or related fields required.

• Minimum of 15 years of relevant experience with external inspections (FDA, OUS notified bodies), product risk (assessing fielded products & making recall decisions) within a Medical Device or highly regulated Manufacturing / Operations environment with 10+ years of managerial experience, or an advanced degree with a minimum of 13 years of relevant experience with external inspections (FDA, OUS notified bodies), product risk (assessing fielded products & making recall decisions) within a Medical Device or highly regulated Manufacturing / Operations environment with 10+ years of managerial experience.

• Must maintain a current and valid Passport, with availability to travel up to 20% annually.

Nice to Have

• Been involved with integrating an acquisition.

• Have experience with FDA remediation (Warning Letter or other).

• Excellent communicator to executive level, fluency in English language.

• Experience working with, ideally leading, global teams.

• Demonstrated ability for transformational actio