Lead Specialist Quality Assurance

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.

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.

• →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.

In specific locations, the pay range may vary from the range posted.