Quality Applications Manager - Quality Data Analytics
Core
Lead strategy and execution of Quality data initiatives, overseeing a team of analysts and developers to produce validated reports for regulatory submissions, audits, and business decisions within the healthcare technology sector.
Role type
Senior Manager, Quality Data Analytics
Builds
Validated data reports, analytics tools, and IT infrastructure for the Quality function
Domain
Healthcare technology / Medical Devices / Regulatory Compliance
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Data analytics, team leadership, regulatory compliance (FDA/21 CFR), IT system validation, stakeholder management, vendor management, continuous improvement methodologies
Preferred skills
Lean/Six Sigma, CMMI, automation/hyper-automation, advanced analytical tools
Technologies
Databricks, Business Objects, Power BI, Power Apps
Responsibilities
Lead strategy and prioritization of Quality data initiatives; Direct and oversee a dynamic team of advanced developers and analysts; Establish working relationships with key stakeholders across Enterprise Quality and IT; Manage a growing portfolio of data and analytics assets; Drive continuous improvement with a focus on efficiency and automation; Represent the function in audits and regulatory inquiries; Guide the team through compliant validation processes for IT systems; Coordinate activities with clients, programmers, and operating personnel; Report on the status of validation activities to fulfill regulatory requirements.
Seniority
Senior, hands-on IC with team management
