QA Analytics Lead - Data-Driven Quality Assurance (Onsite)

3205 St. Jude Medical, Cardiology Division, I; Los Angeles (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

Training and career development

401(k) retirement savings with a match

Health care and well-being programs

Paid time off

Tuition assistance

Job summary

Abbott in Sylmar, CA is seeking a Quality Assurance Lead Specialist to conduct advanced quality data analytics, investigate issues, and ensure compliance with FDA 21 CFR Part 820 and ISO 13485. This onsite role partners with Quality, Operations, Engineering, Regulatory Affairs and Supply Chain.

You will develop dashboards, apply machine learning and predictive analytics, mentor analysts, and translate data insights into actionable improvements across Cardiac Rhythm Management manufacturing and

Qualifications

• Bachelor's degree in life sciences or engineering or an equivalent combination of education and work experience.
• 4+ years of experience applying data analytics in regulated industries such as Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare.
• Proficiency in Python, R, SQL, SAS, or similar analytical languages.
• Experience with machine learning, predictive analytics, anomaly detection, and pattern recognition.

Responsibilities

• Execute advanced quality data analytics and investigations with minimal supervision.
• Lead cross-functional data-driven initiatives for quality improvement, risk reduction, and regulatory compliance.
• Analyze large datasets from CAPA, Complaints, Nonconformances, Supplier Quality, Manufacturing, and Post-Market Surveillance to identify trends and root causes.
• Develop innovative analytical solutions to address quality and operational challenges.
• Apply statistical methods, ML models, and predictive analytics to support decision-making.
• Design, develop, and maintain dashboards and automated quality performance reports.
• Mentor analysts and ensure data governance and validation in regulated environments.
• Collaborate with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams.

Skills

Data analytics

Statistical modeling

Machine learning

Data governance

Education

Bachelor’s degree in life sciences or engineering

Data Science / Statistics related preferred

Tools

Python

R

SQL

SAS

Power BI

Job description

Abbott in Sylmar, CA is seeking a Quality Assurance Lead Specialist to conduct advanced quality data analytics, investigate issues, and ensure compliance with FDA 21 CFR Part 820 and ISO 13485. This onsite role partners with Quality, Operations, Engineering, Regulatory Affairs and Supply Chain.

You will develop dashboards, apply machine learning and predictive analytics, mentor analysts, and translate data insights into actionable improvements across Cardiac Rhythm Management manufacturing and