Quality Systems Engineer CAPA & NC Investigator

REALIGN LLC; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

REALIGN LLC in Irvine, CA is seeking a detail‑oriented Quality Investigator to lead CAPA and Nonconformance investigations within a regulated medical device environment. You will manage containment, data collection, root cause analysis, and corrective actions to ensure timely closure.

Strong documentation, clear communication, and collaboration with cross‑functional teams are essential, as is experience with eQMS tools (ETQ preferred).

Qualifications

• Strong written and verbal communication skills.
• Experience in the medical device industry is a plus.
• Familiarity with CAPA and Nonconformance processes.
• Hands-on CAPA/NC investigations including containment, root cause, corrections, and actions.
• Ability to create clear, evidence-based investigation docs.

Responsibilities

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

Skills

Written & verbal comms

CAPA & NC processes

Quality investigations

eQMS ETQ experience

Cross-functional coordination

Documentation & traceability

Detail-oriented

MS Office suite

Tools

ETQ eQMS

Job description

REALIGN LLC in Irvine, CA is seeking a detail‑oriented Quality Investigator to lead CAPA and Nonconformance investigations within a regulated medical device environment. You will manage containment, data collection, root cause analysis, and corrective actions to ensure timely closure.

Strong documentation, clear communication, and collaboration with cross‑functional teams are essential, as is experience with eQMS tools (ETQ preferred).