🌎
This job posting isn't available in all website languages
📁
Quality
📅
19000MAE Requisition #
Careers That Change Lives
Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday.  It is what makes this an exciting and rewarding place to be.

POSITION DESCRIPTION:

The Senior Director of Corporate Compliance will provide leadership and strategic vision to advance the quality system and compliance maturity of the global Medtronic organization.  In this role, the Senior Director will manage staff to develop and maximize effectiveness of the Corporate Quality System, global compliance services, and global governance through global management review and quality audit programs.  This role will also represent the global MDT quality organization on a variety of internal and external boards and industry committees. The role will require cross functional, cross business and global implementation strategies to influence the highest possible quality in our global Medtronic brand. This position reports to the Vice President, Corporate Quality.

POSITION RESPONSIBILITIES:

Provide leadership and manage team members including: recruiting, developing and retaining top/key education talent, coaching and performance management of staff. 
Prepare and manage budget to align resources to support business objectives. 

Corporate Quality System Management

Maintain an effective and compliant Quality System for Corporate Quality, including QS structure, quality planning, execution of all QS processes, monitoring of metrics, and management review. Manage interactions with external agencies (FDA, Notified Bodies, and Competent Authorities) for inspections of Operation Headquarters.
Provide strategy and compliance consulting to the other corporate functions to ensure they are creating and maintaining effective and compliant Quality Systems where necessary.  Manage the Corporate Quality manual to describe the relationships between the corporate functions and their Quality Systems.
Responsible for the successful execution of the Corporate CAPA Program, including CAPA Board management, corporate procedures related to CAPA, establishing strong business partnership with CAPA board members (e.g. IT, Customer Care, Regulatory, Clinical) and ensuring successful and compliant execution of the CAPAs managed by this board.

Center Led Audit Program 

Provide strategy and oversight to maintain a rigorous global quality audit program (MCARE) to effectively identify systemic quality issues, drive rigorous corrective actions, and improve the overall state of quality system compliance across MDT.
Analyze MCARE audit results to identify trends, and work with global quality partners to drive systemic corrective actions across Medtronic to reduce compliance risk.
Provide internal audit services to corporate groups including audit planning, resourcing, and follow-up to ensure quality system compliance of corporate functions.  Participate in the shared audit program for corporate sites.

Internal / External Engagement

Facilitate Global Quality Management Review.  Assemble the content and analyses for the Medtronic global quality management reviews to ensure executive leadership oversight of key compliance risks.  Present data on behalf of Corporate Quality.
Responsible for supporting and participating in CAPA (TrackWise) tool Global Design; including but not limited to prioritizing change requests, engagement with the businesses in tool requirements and adoption and supporting CAPA Sub-council activities.
Represent MDT global quality on internal committees and boards including the MDT Executive Policy Board and the Global Quality System Harmonization Steering Committee.  
Represent MDT on the AdvaMed inspections sub-council, and additional external councils and committees as requested.  Serve as speaker at industry conferences in the areas of quality systems and compliance.
Lead the Medtronic Compliance Council to effectively identify and communicate compliance risk to the organization and senior leadership leveraging external environment, data, metrics, audit reports, and audit results.    

Global Compliance Services

Develop and implement strategy for a world-class, industry-leading Quality Compliance function ensuring continuous integration of emerging risk areas, and driving rigor into the process across the enterprise. Trend issues in global compliance related to Quality and identify improvement initiatives. Manage the IKM system to communicate and resolve quality issues across MDT. Leverage strong relationships across global businesses, functions and regions to ensure full adoption of global standards.
Must Have: Minimum Requirements 

Bachelor’s degree
Minimum of 15 years of Quality, Compliance or Audit experience with 10+ years of managerial experience, or Advanced Degree with a minimum 13 years prior Quality, Compliance or Audit experience, minimum of 10 years of managerial experience

Nice to Have

Master’s degree in business, management, or legal discipline
Experience working directly with FDA and Notified Bodies
Experience interpreting and implementing US and global medical device regulations (21CFR820, 806, 803, JPAL, MDD, AIMDD, etc.) 
Experience working in a regulated industry (Medical Device or Pharma)
Demonstrated application of risk based approach to the auditing function. 
Advanced experience leading teams and driving strategic, enterprise wide change.
Demonstrated high level of strategic thinking, customer focus risk assessment and judgment.  
Strong interpersonal and communication (both verbal and written) skills.  Ability to facilitate teams and deliver presentations.
Effective relationship management, ability to network, support and influence across organizational and functional boundaries.
Proven success in coaching, developing and managing people; team-building.
Aptitude for new technology


About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.


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 Day in the Life 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.


EEO 
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.