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Quality Applications Manager - Quality Data Analytics

Medtronic

Job Overview The Quality Applications Manager – Quality Data Analytics oversees a team of analysts responsible for producing accurate, timely, and validated reports from our Complaint Handling and other quality systems. The role reports to the Global Quality Strategy & Insights leader in Core Quality Services (CQS) and works closely with OU Quality teams and CQS Customer Quality. Onsite U.S. locations include: Mounds View, MN; Irvine, CA; Boulder, CO; Danvers, MA; North Haven, CT; Memphis, TN; Fort Worth, TX; Jacksonville, FL. Travel up to 20% per year. Responsibilities Lead strategy, prioritization, and execution of quality data initiatives that improve data quality, access, automation, self‑service analytics, visualization, and insight generation across Quality. Direct and oversee a dynamic team of developers and analysts planning and executing tools, reports, and data insights. Establish and maintain effective relationships with key stakeholders across the Enterprise with focus on Quality and IT. Manage a growing portfolio of data and analytics assets and IT infrastructure to ensure continuity and continuous improvement. Establish management mechanisms that drive team accountability, execution, effective communication, and cohesion. Oversee initiatives that drive continuous improvement focusing on efficiency and automation. Manage vendor relationships and contracts. Represent and support the Quality Data Analytics function in audits and regulatory inquiries. Guide team through compliant validation processes for quality IT systems and reports, producing documentation such as 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 for implementation and maintenance of procedures, actions, and documentation required for regulatory compliance. Report on the status of validation activities to fulfill regulatory requirements. Keep abreast of changing federal and international regulatory requirements, audit policies, and current techniques. Support the design, administration, and configuration of quality IT systems. Minimum Requirements Bachelor’s degree with minimum 5 years of relevant experience in complaint handling, regulatory submissions/inquiries, and data analytics, OR advanced degree with minimum 3 years of relevant experience. For Baccalaureate degrees earned outside the U.S., a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Nice to Have Knowledge of medical device quality systems (CAPA, Audit, Configuration Assurance, Training, FCA/PHO, Complaint Handling). Understanding of IT systems, applications, data flow, databases, integration methodologies, core systems such as Databricks, Business Objects, Power BI, Power Apps. Experience in automation technologies, tools, or processes. Analytical mindset, problem‑solving, and advanced analytical tools and methods. Continuous improvement mindset (Lean/Six Sigma, CMMI certification or similar). Program management skills for simultaneous initiatives. Excellent communication and collaboration skills. People leadership and talent development. Physical Job Requirements Regular mobile, interaction with a computer, and communication with peers and co‑workers. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. U.S. Work Authorization & Sponsorship Roles below Principal level require unrestricted U.S. work authorization at time of hire and for the duration of employment. Equal Employment Opportunity Medtronic provides equal employment opportunity under federal, state, and local laws. The company provides reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr Medtronic

Vacancy posted more than 2 months ago

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