Quality Systems Investigator - CAPA & NC (Med Device)

Tata Consultancy Services Limited; Irvine (CA); Vor Ort; USD 70.000 - 80.000; Vollzeit

Benefits dieser Stelle

Discretionary Annual Incentive

Comprehensive Medical Coverage

Family Leave

Insurance Options

Commuter Benefits

Certification & Training Reimbursement

Vacation & Holidays

Legal & Financial Assistance

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication skills

CapA & NC processes

Quality investigations

Documentation & evidence-based writing

Cross-functional coordination

Problem-solving & root cause analysis

eQMS familiarity

MS Office suite

Ausbildung

Bachelor of Computer Science

Tools

ETQ

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Teams

Jobbeschreibung

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