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 Leaves Support

Commuter Benefits & Training Reimburse

Job summary

Tata Consultancy Services Limited in Irvine, CA is seeking an Engineer to execute and manage CAPA and NC investigations within a medical-device quality system. You will coordinate with cross-functional teams, apply root cause analysis, and maintain compliant investigation records.

The role requires strong documentation, communication, and organizational skills, with familiarity in ETQ and MS Office tools. Great for candidates with CAPA experience in the medical device sector.

Qualifications

• Strong written and verbal communication and ability to clearly document and present investigation outcomes.
• Experience in the medical device industry is a plus.
• Working knowledge of CAPA and Nonconformance (NC) processes.
• Hands-on experience managing quality investigations including containment, root cause analysis, corrections and actions.
• Ability to develop clear, objective, evidence-based investigation documentation that is traceable and inspection-ready.
• Strong organizational and follow-up skills to coordinate day-to-day activities and timelines with cross-functional stakeholders.
• Ability to prioritize multiple investigations and quality-system deliverables with attention to detail.
• Experience using an electronic Quality Management System (eQMS); ETQ experience preferred.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook and Teams.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures and quality-system requirements.
• Lead investigation activities from initiation through closure, including containment, data collection, root cause analysis, corrections and action plans.
• Apply structured problem-solving and root cause analysis to determine causes of quality issues and support risk-based decisions.
• Coordinate with investigation owners, process owners, SMEs, and cross-functional users to obtain objective evidence and complete actions.
• Facilitate routine investigation follow-up meetings, document decisions and actions, and communicate risks, delays, and escalations.
• Ensure investigation records are accurate, clear, complete, timely, and evidenced.
• Track CAPA, NC, and investigation milestones; maintain visibility of open actions and timely closure.
• Enter and maintain quality records in the eQMS; ETQ experience preferred.
• Support quality-system metrics, trend reviews, internal audits, and regulatory or customer inspections.
• Identify opportunities to improve investigation quality, workflow efficiency, and user compliance with procedures.
• Perform other quality-system duties as assigned.

Skills

Communication skills

CAPA knowledge

NC knowledge

Documentation

Cross-functional coordination

Prioritization

MS Word

MS Excel

MS PowerPoint

MS Outlook

MS Teams

Education

Bachelor of Computer Science

Tools

ETQ

MS Excel

MS Word

PowerPoint

Outlook

Teams

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