New

Quality Systems Engineer

Tata Consultancy Services
$70,000 - $80,000
sick time, 401(k)
United States, California, Irvine
Oct 29, 2026
Job Description Must Have Technical/Functional Skills * Strong written and verbal communication skills, with the ability to clearly document and present investigation outcomes. * Previous experience in the medical device industry; prior experience is a plus. * Working knowledge of Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes. * Hands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions. * Ability to develop clear, objective, and evidence-based investigation documentation that is complete, traceable, and inspection-ready. * Strong organizational and follow-up skills to coordinate day-to-day activities, action items, timelines, and meetings with system users and cross-functional stakeholders. * Ability to prioritize multiple investigations and quality-system deliverables while maintaining attention to detail. * Experience using an electronic Quality Management System (eQMS); ETQ experience is preferred. * Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams. Roles & Responsibilities * Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements. * Lead investigation activities from initiation through closure, including containment, issue bounding, data collection, root cause analysis, corrections, corrective actions, and effectiveness planning, as applicable. * Apply structured problem-solving and root cause analysis methods to determine the cause of quality issues and support risk-based decisions. * Coordinate with investigation owners, process owners, subject-matter experts, and other cross-functional users to obtain objective evidence and complete assigned actions. * Facilitate routine investigation follow-up meetings, document decisions and action items, and proactively communicate risks, delays, and escalations. * Ensure investigation records are accurate, clear, complete, timely, and supported by appropriate evidence and rationale. * Track CAPA, NC, and investigation milestones; maintain visibility of open actions and support timely closure. * Enter, update, route, and maintain quality records in the applicable eQMS; experience with ETQ is preferred. * Support quality-system metrics, trend reviews, internal audits, and regulatory or customer inspection readiness, as assigned. * Identify opportunities to improve investigation quality, workflow efficiency, and user compliance with established procedures. * Perform other quality-system duties as assigned. Salary Range: $70,000 - $80,000 a year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1 Location Irvine, CA Function TECHNOLOGY Role Engineer ID 431105 Skills MS Excel \| Medical Device NPD Salary Range $70,000 - $80,000 Desired Candidate Profile Qualifications BACHELOR OF COMPUTER SCIENCE