Quality Applications Manager - Quality Data Analytics

Quality Applications Manager - Quality Data Analytics

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 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 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 position is onsite at any U.S. site listed.

The Quality Applications Manager - Quality Data Analytics operates with stakeholders and team members located across multiple regions. This role is critical to ensure the successful completion of critical reporting activities in the Quality Analytics Team and project deliverables as part of the eQMS roadmap.

This position will be onsite, based at one of the following Medtronic sites in the contiguous United States:

• Mounds View, MN / Minneapolis, MN (Twin Cities Campus)
• Irvine, CA / Santa Ana, CA (Orange County Campus)
• Boulder, CO (Colorado Campus)
• Danvers, MA (Greater Boston area)
• North Haven, CT
• Memphis, TN
• Fort Worth, TX
• Jacksonville, FL

Requires up to 20% travel per year.

As the Quality Applications Manager - Quality Data Analytics, your key responsibilities will include the following (and other duties may be assigned):

• Lead the strategy, prioritization, and execution of Quality data initiatives that improve data quality, access, automation, self-service analytics, visualization, and insight generation across the Quality organization.
• Direct and oversee a dynamic team of advanced developers and analysts that plan and execute actions, develop tools and reports, and provide insights on Quality data.
• Establish and maintain effective working relationships with key stakeholders across the Enterprise with a focus on Quality and IT.
• Manage a growing portfolio of data and analytics assets and information technology infrastructure to ensure continuity and continuous improvement.
• Establish and maintain management mechanisms to drive team accountability, execution, effective communication, and cohesion.
• Oversee initiatives that drive continuous improvement with a focus on efficiency and automation
• Manage vendor relationships and contracts.
• Represent and support the Quality Data Analytics function in audits and regulatory inquiries.
• Guide their team through the regular use of a compliant validation process for quality information technology systems and reports, which requires formal validation documentation (including standard operating procedures) to meet appropriate regulations.
• Coordinate activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
• Identify current and anticipated requirements for compliant computerized operations and suggest 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 that govern the user's applications.
• Report on the status of validation activities to fulfill regulatory requirements.
• Keep abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Support the design, administration, and configuration of quality information technology systems.

Must Have: Minimum Requirements

• Bachelor's degree required with a minimum of 5 years of relevant experience in complaint handling, regulatory submissions/inquiries and data analytics: OR an advanced degree with a minimum of 3 years of relevant experience in complaint handling, regulatory submissions/inquiries and data analytics.

Nice to Have

• Quality systems knowledge for medical device or similar regulated industry (i.e. CAPA, Audit, Configuration Assurance, Training, FCA/PHO, Complaint Handling, etc.).
• Understanding of IT systems, applications, data flow, and databases, as well as integration methodologies and best practices. Knowledge in core systems such as Databricks, Business Objects, Power BI, and Power Apps.
• Experience in automation (inclusive of hyper automation) technologies, tools, or processes.
• Analytical mindset: Problem-solving abilities to identify risks, evaluate options, and make informed decisions; experience with advanced analytical tools and methods.
• Continuous improvement mindset: Lean/Six sigma, CMMI certification or similar.
• Program Management: focus on high-quality, high-ethics execution and removal of roadblocks; ability to manage multiple initiatives simultaneously.
• Excellent communicator: active listening, verbal, and written; ability to collaborate effectively with and influence cross-functional teams and stakeholders.
• People Leadership: create effective interpersonal relationships; motivate, engage, and grow talent.

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.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.

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):$120,000.00 - $180,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).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