Sr Compliance Director - Core Quality Services

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 LifeJoin 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 action (Medtronic Star of Excellence equivalent).

• Adept at visual management to communicate goals and progress on KPI’s.

• Ability to attract and build organizational talent, internal and external to Medtronic.

• Have lived abroad.

• Black Belt certified or equivalent.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$217,600.00 - $326,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.