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,…