Quality Systems Investigator - CAPA & NC (Med Device)

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

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