Quality Analytics Leader, AI & Data Solutions

Edwards Lifesciences; Irvine (CA); Presencial; USD 121 000 - 171 000; Tempo integral

Resumo da oferta

Edwards Lifesciences in California seeks a Data Analytics Quality Manager to lead Quality System improvements, analytics insights, and AI-enabled solutions to identify risks and trends, driving cross-functional projects. You will oversee QA processes, CAPA, and data governance while partnering with IT, Regulatory, and Manufacturing teams.

The role emphasizes developing robust data models, validating BI reports, and mentoring staff, with a focus on compliance with FDA ISO standards.

Qualificações

• Bachelor's or equivalent in a related field with 8+ years in quality/manufacturing in the medical device industry
• Master's or equivalent in a related field with 6+ years in quality/manufacturing in the medical device industry
• Advanced BI tools experience (Power BI, Tableau, Streamlit)
• Experience with Quality Systems, Post Market regulatory and Training data
• Experience validating BI reports and analytics solutions
• Experience with databases (Snowflake, Databricks, JDE, MES, EQMS, LMS) and programming languages (SQL, Python)
• Strong documentation, communication and stakeholder management skills
• Familiarity with Edwards' policies and ISO/FDA regulations

Responsabilidades

• Identify, lead and provide business process improvement solutions for Quality Systems, including 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 and assess effectiveness
• Drive investigations, root cause analysis, corrective actions and monitoring plans
• Review and identify actions from metrics
• Lead AI initiatives and deploy AI Agents to support operations
• Prepare and pre-review data and documents for integrity prior to audits
• Provide technical direction to lower level staff
• Other duties assigned by Leadership

Conhecimentos

Power BI

Tableau

Streamlit

SQL

Python

Data analytics

Formação académica

Bachelor's degree

Master's degree

Ferramentas

Snowflake

Databricks

JDE

MES

EQMS

LMS

Descrição da oferta de emprego

Edwards Lifesciences in California seeks a Data Analytics Quality Manager to lead Quality System improvements, analytics insights, and AI-enabled solutions to identify risks and trends, driving cross-functional projects. You will oversee QA processes, CAPA, and data governance while partnering with IT, Regulatory, and Manufacturing teams.

The role emphasizes developing robust data models, validating BI reports, and mentoring staff, with a focus on compliance with FDA ISO standards.