Quality Applications Manager

Medtronic • Lafayette, MN

37d • $120,000 - $180,000 • Onsite

About The Position

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 Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Applications Manager, you will lead a team of Quality Technologists to drive technology innovation as part of Medtronic's Customer Quality Excellence Organization. Your responsibilities will focus on managing, strategizing and implementing innovative solutions to enhance quality, ensure compliance, and create efficiencies within Complaint Handling, Field Corrective Actions and Product Hold Order processes. As part of our Strategy & Innovation team, this role will be dedicated to developing robust, intelligent technologies through strong collaboration with internal and external partners. Together, you will advance Customer Quality's (CQ) vision of fostering positive patient outcomes, ensuring confident compliance, and leveraging scale through best-in-class processes and a culture of innovation. Responsibilities may include the following and other duties may be assigned.

Requirements

• A bachelor’s degree in is required
• 5+ years of relevant experience or advanced degree with a minimum of 3+ years prior relevant experience
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Experience contributing to or leading strategy development, including roadmap planning, prioritization of enhancements, and alignment with quality and business objectives
• Complaint Handling or FCA/PHO experience
• Working knowledge of global quality and regulatory standards (e.g., FDA, ISO 13485, ISO 14971)
• Background in cross-functional collaboration with Quality, IT, Regulatory, and business stakeholders to translate quality needs into system solutions

Responsibilities

• Leads a global team of Quality Application Specialists and Software Engineers to deliver technology solutions in alignment with business needs.
• Develops a strong team culture of high engagement and collaboration, supporting team members on their development and growth at Medtronic.
• Partners with CQ functions and stakeholders to drive process improvements and technology advancements across the Complaint Handling, Field Corrective Action and Product Hold Order process lifecycles.
• Partners with Medtronic’s AI teams to deliver ML/AI-driven solutions, reporting, and analytics.
• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager