Senior Quality Analyst, Data Analytics

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Analyst, Data Analytics position is a unique career opportunity that could be your next step towards an exciting future.

This Senior Analyst plays a critical role in analyzing product complaint data to support Quality Compliance investigations, corrective actions, regulatory submissions, and continuous feedback to R&D for product improvement and innovation.  This position ensures data accuracy and integrity through standardization, automation, data clean-up, and quality monitoring, while collaborating closely with cross-functional stakeholders. The role is key to transforming complex data into actionable insights that drive compliance, enhance product safety, and support global regulatory requirements.

How you’ll make an impact:

• 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.

What you’ll need (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.

What else we look for (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.

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.
The base pay range for this position is $90,000 to $127,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.