Director, Post-Market Quality

We anticipate the application window for this opening will close on - 1 Aug 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 LifeWe bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to do our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This is an onsite role located in Lafayette, CO.
As a Director of Post-Market Quality based in Lafayette, CO, you will lead a team responsible for ensuring the safety, compliance, and performance of our products after they reach the market. This role is critical to our mission of
alleviating pain, restoring health, and extending life.

As the Director of Post-Market Quality, you will:

• Lead the post-market surveillance function, including complaint trending, signal detection, and risk escalation.
• Oversee Field Corrective Action (FCA) activities, ensuring timely and compliant execution across global markets.
• Serve as the primary liaison for regulatory agency inquiries related to post-market product performance.
• Direct product hold and release processes in collaboration with cross-functional teams.
• Partner with Regulatory Affairs, Clinical, R&D, and Operations to drive continuous improvement and ensure product safety and compliance.
• Represent the Quality function in management reviews, audits, and strategic planning forums.
• Develop and mentor a high-performing team of quality professionals.

Must Have: Minimum Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in Quality Assurance or Regulatory Affairs within the medical device industry (or 8+ years with an advanced degree)
• 7+ years of leadership experience managing teams and cross-functional initiatives.
• Deep knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and global post-market regulatory requirements.
• Demonstrated success in managing complaint handling, CAPA, and field actions.

Nice to Have

• Advanced degree (MS, MBA, or equivalent).
• Experience with enterprise quality systems (e.g., TrackWise, Veeva).
• Strong communication and stakeholder engagement skills.
• Experience interacting with FDA, Notified Bodies, and other regulatory agencies.

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):$180,800.00 - $271,200.00

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.