Quality Systems Engineer

Tata Consultancy Services; Irvine (CA); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Discretionary Annual Incentive

Comprehensive Medical Coverage

Family Leave

Insurance Options

Commuter Benefits

Certification & Training Reimbursement

Vacation & Holidays

Legal & Financial Assistance

Job summary

Tata Consultancy Services in Irvine, California seeks a quality investigations professional to lead CAPA and NC processes, manage containment, data collection, and root-cause analysis. You will document evidence-based investigations, coordinate with cross-functional teams, and drive timely closure while maintaining compliance with the quality system.

Must have CAPA/NC experience in medical devices, strong communication skills, and proficiency in ETQ or similar eQMS tools; MS Office suite

Qualifications

• Strong written and verbal communication skills with documentation and presentation abilities.
• Experience in the medical device industry is a plus.
• Working knowledge of CAPA and Nonconformance processes.
• Hands-on quality investigations including containment, root cause analysis, and corrective actions.
• Ability to produce clear, traceable, evidence-based investigation records.
• Experience using an electronic Quality Management System (eQMS); ETQ preferred.
• Proficiency with MS Word, Excel, PowerPoint, Outlook, and Teams.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures and quality-system requirements.
• Lead investigations from initiation to closure including containment, data collection, root-cause analysis, and effectiveness planning.
• Apply structured problem-solving to determine causes of quality issues and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users to obtain evidence and complete actions.
• Facilitate follow-up meetings, document decisions, and communicate risks, delays, and escalations.
• Ensure investigation records are accurate, timely, and well-evidenced.
• Track milestones for CAPA, NC, and investigations and maintain visibility of open actions.
• Maintain quality records in the eQMS; ETQ experience is preferred.
• Support quality-system metrics, audits, and inspection readiness as assigned.
• Identify opportunities to improve investigation quality and workflow efficiency.

Skills

Communication skills

CapA & NC processes

Quality investigations

Documentation & evidence-based writing

Cross-functional coordination

Problem-solving & root cause analysis

eQMS familiarity

MS Office suite

Education

Bachelor of Computer Science

Tools

ETQ

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Teams

Job description

• 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.
• 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.

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.

Qualifications:

BACHELOR OF COMPUTER SCIENCE