Lead Specialist Quality Assurance

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Abbott is seeking a Quality Assurance Lead Specialist in Sylmar, CA for onsite work focusing on quality analytics and regulatory compliance. You will independently conduct advanced analytics, lead cross-functional data initiatives, and develop dashboards and reports to improve quality and reduce risk.

The role requires a strong background in statistics, data science, and quality systems, with experience in CAPA, complaints, and post-market surveillance.

Qualifications

• Bachelor’s degree in life sciences or engineering required.
• Regulated industry experience (medical devices/pharma) preferred.
• Strong programming and data analysis skills with Python/R/SQL/SAS.
• Experience with data governance and regulatory compliance highly valued.

Responsibilities

• Independently execute advanced quality data analytics with minimal supervision.
• Lead cross-functional data-driven initiatives for quality improvement.
• Analyze large datasets from CAPA, complaints, nonconformances, and more.
• Develop analytical solutions to address quality and operational challenges.
• Apply machine learning and predictive analytics to detect quality issues.
• Design dashboards and automate quality performance reports.
• Mentor analysts and collaborate with Quality, Operations, Engineering, Regulatory.
• Support regulatory inspections and quality system monitoring.

Skills

Python

R

SQL

SAS

Data analytics

Machine learning

Statistics

Data visualization

Power BI

Quality analytics

Education

Bachelor's degree in life sciences or engineering

Preferred degree in data science / statistics / CS

Tools

Infinity QS

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

MAIN PURPOSE OF THIS ROLE

We are seeking a highly qualified Quality Assurance Lead Specialist in Sylmar, CA to conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements.

This is an ONSITE role.

WHAT YOU'LL DO

• Responsible for independently executing advanced quality data analytics and investigation activities with minimal management oversight.
• Lead cross-functional data-driven initiatives focused on quality improvement, risk reduction, process optimization, and regulatory compliance.
• Analyze large and complex datasets from CAPA, Complaints, Nonconformances, Supplier Quality, Manufacturing, and Post-Market Surveillance systems to identify trends, signals, and root causes.
• Develop innovative, practical, and compliant analytical solutions to address complex quality and operational challenges.
• Apply statistical methods, machine learning models, and predictive analytics to proactively detect emerging quality issues and support decision-making.
• Design, develop, and maintain dashboards, automated reports, and quality performance metrics to provide actionable insights across the organization.
• Demonstrate expertise in data science, statistical analysis, and quality systems while continuously expanding technical and leadership competencies.
• Identify opportunities for continuous improvement through data-driven analysis and recommend sustainable solutions.
• May provide technical guidance and mentorship to analysts, quality professionals, data scientists, and contractors.
• Maintain specialized expertise in Quality Analytics while leveraging knowledge of manufacturing, regulatory, engineering, and business processes.
• Collaborate closely with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams to solve complex business problems.
• Represent the Data Science and Quality Analytics function on cross-functional projects and strategic initiatives.
• Implement tactical and strategic analytics activities to support quality objectives and business priorities.
• Contribute advanced statistical and data science expertise broadly across business functions.
• Directly influence project direction, investigation strategies, analytical methodologies, and quality risk management decisions through evidence-based insights.
• Support regulatory inspections, management reviews, CAPA effectiveness assessments, and quality system monitoring through robust data analysis and visualization.
• Ensure data integrity, governance, and compliance with applicable requirements including FDA 21 CFR Part 820, ISO 13485, and internal quality management system standards.

QUALIFICATIONS

Education

• Bachelors Degree ( ± 16 years) In life sciences or engineering or an equivalent combination of education and work experience.
• Preferred degree in Data Science, Statistics, Biostatistics, Computer Science, Engineering, Mathematics, Quality Engineering, or a related quantitative field.

Experience/Background

• Minimum 4 years of experience applying data analytics, statistical modeling, and data science techniques in a regulated industry such as Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare.
• Strong proficiency in Python, R, SQL, SAS, or similar analytical programming languages.
• Experience with machine learning, predictive analytics, anomaly detection, and pattern recognition methodologies.
• Advanced knowledge of statistical analysis techniques including hypothesis testing, regression analysis, multivariate analysis, survival analysis, DOE (Design of Experiments), SPC (Statistical Process Control), and time-series analysis.
• Experience working with large and complex datasets from Manufacturing, Quality Systems, Complaints, CAPA, Nonconformance, Supplier Quality, and Post-Market Surveillance systems.
• Proficiency with data visualization and business intelligence tools such as Power BI, Infinity QS.
• Experience developing interactive dashboards, automated reporting solutions, and executive-level data presentations.
• Strong understanding of data governance, data integrity, and validation principles in regulated enviro