Data Analytics Quality Manager

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

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

Power BI

Tableau

Streamlit

SQL

Python

Data analytics

Education

Bachelor's degree

Master's degree

Tools

Snowflake

Databricks

JDE

MES

EQMS

LMS

Job description

Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions.

At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

The manager for Data Analytics Quality Manager will be responsible for leading Quality System improvements, Quality Analytics Insights, and AI-enabled solutions to identify risks and trends, drive cross-functional projects and corrective actions, and strengthen operational effectiveness, compliance, and data-driven decision-making.

How you will make an impact:

• Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience
• Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams
• Manage all phases of the small to medium quality systems (e.g.,Training, CAPA, NCR, Supplier, FCA, PRA)
• Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others
• Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs
• 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 presentation in internal and external audit activities
• Provide technical direction to lower level staff
• Other incidental duties assigned by Leadership

What you'll need (required):

• Bachelor's Degree or Equivalent in related field, 8 years’ quality and/or manufacturing environment in the medical device industry experience or equivalent work experience based on Edwards criteria or
• Master's Degree or equivalent in related field, 6 years’ experience quality and/or manufacturing environment in the medical device industry experience or equivalent work experience based on Edwards criteria

What else we look for (preferred):

• Excellent in business intelligence applications (e.g., Power BI, Tableau, Stream lit)
• Experience with Quality Systems, Post Market , Regulatory and Training data or equivalent work experience based on Edwards criteria
• Experience in authoring and executing validation for business intelligence reports
• Experience with databases (e.g., Snowflake, Databricks, JDE, MES, EQMS, LMS)
• Experience with programming languages (e.g, SQL, Python, etc)
• Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of Edwards’ policies, procedures, and guidelines relevant to quality systems
• Experience in architecting, developing and deploying business intelligence, analytics and reporting solutions to internal and external stakeholders
• Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
• Ability to transfer essential knowledge and mentor other team members on specialized skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team
• Ability to consult in a project setting within specific sections
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental)

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $121,000 - $171,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.