Quality Analytics & AI Lead – BI for Medical Devices

Edwards; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Edwards Lifesciences is seeking a Data Analytics Quality Manager to lead Quality System improvements, analytics insights, and AI-enabled solutions. You will drive cross-functional projects, CAPA, and data-driven decision making while ensuring regulatory compliance and operational excellence.

The role requires 8+ years in quality/manufacturing in medical devices (or Edwards criteria) and expertise in BI tools, databases, and programming languages.

Qualifications

• Bachelor's Degree or Equivalent in related field; 8+ years quality/manufacturing in medical device industry or Edwards criteria
• Master's Degree or Equivalent in related field; 6+ years quality/manufacturing in medical device industry or Edwards criteria

Responsibilities

• Identify and lead business process improvements for Quality Systems, reviewing and approving changes to procedures
• Lead moderately complex projects from inception through completion with milestones and resources
• Manage all phases of small to medium quality systems (Training, CAPA, NCR, Supplier, FCA, PRA)
• Review and approve changes to documentation related to Quality Systems and assess effectiveness
• Drive root cause analyses, implement corrective actions, and monitor results with cross-functional SMEs
• Lead AI initiatives and deploy AI Agents to support operations
• Prepare data and documents for integrity before internal/external audits
• Provide technical direction to junior staff
• Align with Leadership on incidental duties

Skills

Power BI

Tableau

Python

SQL

Education

Bachelor's Degree

Master's Degree

Tools

Snowflake

Databricks

JDE

MES

EQMS

LMS

Job description

Edwards Lifesciences is seeking a Data Analytics Quality Manager to lead Quality System improvements, analytics insights, and AI-enabled solutions. You will drive cross-functional projects, CAPA, and data-driven decision making while ensuring regulatory compliance and operational excellence.

The role requires 8+ years in quality/manufacturing in medical devices (or Edwards criteria) and expertise in BI tools, databases, and programming languages.