Quality Systems Investigator - CAPA & eQMS Expert

Q1 Technologies, Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Q1 Technologies, Inc. seeks a quality investigations professional to lead CAPA and NC activities across the quality system. You will manage investigations from containment through closure, collect data, determine root causes, implement corrections, and validate effectiveness.

Ideal candidates have strong documentation skills, familiarity with eQMS tools like ETQ, and experience coordinating with cross-functional teams to ensure timely closure and compliance with regulatory requirements.

Qualifications

• Strong written and verbal communication for documenting and presenting 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 from containment to closure.
• Ability to develop clear, traceable investigation documentation.

Responsibilities

• Lead investigation activities from initiation through closure, including containment, data collection, root cause analysis, corrections, and actions.
• Coordinate with owners, process owners, and stakeholders to obtain objective evidence.
• Maintain investigation records with appropriate evidence and rationale.
• Enter and maintain quality records in the eQMS; ETQ experience preferred.
• Support quality-system metrics, internal audits, and regulatory inspections.

Skills

Communication

CAPA/NC processes

Investigation management

Root cause analysis

Documentation

Cross-functional coordination

Structured problem-solving

eQMS familiarity

MS Office

Tools

ETQ

Microsoft Office

Job description

Q1 Technologies, Inc. seeks a quality investigations professional to lead CAPA and NC activities across the quality system. You will manage investigations from containment through closure, collect data, determine root causes, implement corrections, and validate effectiveness.

Ideal candidates have strong documentation skills, familiarity with eQMS tools like ETQ, and experience coordinating with cross-functional teams to ensure timely closure and compliance with regulatory requirements.