Edwards Lifesciences · 15 hours ago
Senior Analyst, Data Analytics
USA - California – Irvine
Full-time
Onsite
Mid, Senior Level
$90K/yr - $127K/yr
5+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Senior Analyst, Data Analytics position involves analyzing product complaint data to support Quality Compliance investigations and regulatory submissions while ensuring data accuracy and integrity through standardization and automation.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Identify appropriate categories of complaint data, summarize and perform complex analysis for custom ad hoc reports
Create customized reports to analyze complaint data utilized by Quality Compliance and other cross functional teams to ensure data integrity, recognize trends and/or anomalies and perform complex analysis
Develop monthly and quarterly complaint trend reports with the knowledge of multiple different statistical tools (e.g., Laney P, Laney U, G Chart, T-test). Prepare presentations for monthly and quarterly Quality meetings, and for distribution to regional regulatory affiliates and executive leadership
Aggregate data from different data sources (e.g., various PowerBi Reports, JDE, QMS) for the generation and distribution of weekly complaint and evaluation reports while ensuring data integrity. Troubleshoot discrepancies and delegate to the appropriate personnel for correction
Provide continuous process improvement in report analysis and trending methods
Develop tools to streamline complex data analysis processes
Create dashboards to enhance reporting efficiency
Identify issues and provide recommendations for process improvement
Partner with stakeholders to establish the single source of truth and govern data quality for complaint reporting by data standardization, data automation, data clean up, and data quality/monitoring
Other incidental duties
Qualification
Required
Bachelor's Degree plus at least 5 years of combined experience with data analytics, quality, or regulatory; or equivalent work experience based on Edwards' criteria
Preferred
Degree in Engineering, Data Analytics, Statistics, Scientific, Regulatory, or related fields
Highly regulated industry (medical device, pharmaceutical, biotech, aerospace, automotive, etc.)
Hands-on experience with data visualization (e.g. dashboards) and enterprise tools such as Power BI, Tableau, QlikView, and SAP
Strong ability to extract, manipulate, and analyze data from multiple systems and sources
Solid understanding of Quality Management Systems (QMS) and regulatory requirements (e.g., FDA, ISO 13485)
Experience performing data mining, trend analysis, and KPI reporting to support compliance and decision-making
Knowledge and experience with Quality Systems (e.g. CAPAs, NCRs, Complaints)
Ability to harmonize reporting processes across multiple stakeholders and geographies
Advanced proficiency in Excel, including pivot tables, complex formulas, and data analysis
Familiarity with SQL queries for data extraction and analysis
Excellent communication skills with the ability to present complex data clearly to cross-functional teams
Knowledge of complaint handling processes and post-market surveillance requirements
Strong analytical mindset with attention to detail and data integrity
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase