Quality Analytics Lead - Medical Devices

Abbott; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Abbott in Sylmar, CA seeks a Quality Assurance Lead Specialist to independently execute advanced quality data analytics and investigations, driving cross-functional data-driven initiatives to improve quality, reduce risk, and ensure regulatory compliance in a highly controlled medical device environment.

You will design dashboards, apply ML and predictive analytics, mentor analysts, and collaborate with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams, while

Qualifications

• Minimum 4 years applying data analytics in regulated environments.
• Strong proficiency in Python, R, SQL, SAS or similar languages.
• Experience with machine learning, predictive analytics and anomaly detection.
• Knowledge of statistical techniques: hypothesis testing, regression, time-series.

Responsibilities

• Execute advanced quality data analytics and investigations with minimal oversight.
• Lead cross-functional data-driven initiatives for quality improvement and regulatory compliance.
• Analyze large datasets from CAPA, Complaints, Nonconformances, Supplier Quality, Manufacturing, and Post-Market Surveillance.
• Develop analytical solutions to address complex quality and operational challenges.
• Apply ML and predictive analytics to detect emerging quality issues and support decisions.
• Design and maintain dashboards, automated reports, and quality metrics.
• Provide technical guidance and mentor analysts and contractors.
• Collaborate with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams.

Skills

Python

R

SQL

SAS

Power BI

Statistical Modeling

Time-series analysis

Data Visualization

Education

Bachelors Degree in life sciences or engineering

Preferred: Data Science / Statistics / Biostatistics

Tools

Infinity QS

Job description

Abbott in Sylmar, CA seeks a Quality Assurance Lead Specialist to independently execute advanced quality data analytics and investigations, driving cross-functional data-driven initiatives to improve quality, reduce risk, and ensure regulatory compliance in a highly controlled medical device environment.

You will design dashboards, apply ML and predictive analytics, mentor analysts, and collaborate with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams, while