Quality Applications Manager - Quality Data Analytics

Job Summary

We are looking for a Quality Applications Manager – Quality Data Analytics to lead a team of analysts in producing accurate reports from complaint handling and other quality systems. The role supports business decisions, regulatory submissions, audits, and strategic decisions within the Quality function.

Position is onsite at one of the following U.S. sites:

• 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.

• Lead 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 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 IT infrastructure to ensure continuity and continuous improvement.
• Establish and maintain management mechanisms that 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 the team through the use of a compliant validation process for quality IT systems and reports, requiring formal validation documentation (including SOPs) to meet regulations.
• Coordinate activities with clients, programmers/developers, and operating personnel, domestically and globally as appropriate.
• Identify current and anticipated requirements for compliant computerized operations and suggest methods to implement and maintain the necessary procedures, actions, and documentation.
• Report status of validation activities to fulfill regulatory requirements.
• Keep abreast of changing federal and international regulatory requirements, government audit policies, and new techniques.
• Support the design, administration, and configuration of quality IT systems.

• Bachelor’s degree with at least 5 years of experience in complaint handling, regulatory submissions/inquiries, and data analytics (advanced degree with at least 3 years of experience is acceptable).
• Experience in complaint handling, regulatory submissions/inquiries, and data analytics.
• Quality systems knowledge for medical device or similar regulated industry (CAPA, Audit, Configuration Assurance, Training, FCA/PHO, Complaint Handling, etc.).
• Understanding of IT systems, applications, data flows, and databases, as well as integration methodologies and best practices.
• Knowledge of core systems such as Databricks, Business Objects, Power BI, and Power Apps.
• Experience in automation technologies, tools, or processes.
• Analytical mindset with 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 with ability to manage multiple initiatives simultaneously.
• Excellent communicator (active listening, verbal, and written) with ability to collaborate effectively with cross‑functional teams and stakeholders.
• People leadership ability to motivate, engage, and grow talent.
• For U.S. work authorization: unrestricted U.S. work authorization at the time of hire and for the duration of employment.

• Experience with hyper‑automation technologies.
• Knowledge of additional regulated quality processes beyond those listed above.

Salary range: $120,000 – $180,000 USD (U.S. locations, excluding Puerto Rico). Eligible for Medtronic Incentive Plan (MIP) and additional short‑term incentive. Benefits may include medical, dental, vision insurance;
Health Savings Account;
Flexible Spending Account; life insurance; long‑term disability; dependent daycare; tuition assistance; 401(k) with employer match; short‑term disability; paid time off; paid holidays; employee stock purchase plan; employee assistance program; and other plans based on location.

Medtronic is an equal‑opportunity employer and considers applicant qualifications regardless of race, color, national origin, citizenship status, disability, gender, sexual orientation, gender identity, or any characteristic protected by law. Reasonable accommodations are provided for qualified individuals with disabilities.