CAPA & Investigation Lead - Quality Systems

REALIGN LLC; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

REALIGN LLC in Irvine, CA seeks a CAPA/NC Investigator to lead quality investigations within the medical device quality system. You will drive containment, root-cause analysis, corrections, and preventive actions, ensuring evidence-based, traceable documentation.

You will coordinate with cross-functional teams, maintain timely records, and support regulatory or customer inspections with rigorous adherence to procedures and traceability.

Qualifications

• Strong written and verbal communication skills; ability to document and present investigation outcomes clearly.
• Experience in the medical device industry; prior experience is a plus.
• Working knowledge of CAPA and Nonconformance (NC) processes.
• Hands-on experience managing quality investigations: containment, issue bounding, RCA, corrections, and actions.
• Clear, objective investigation documentation that is traceable and inspection-ready.

Responsibilities

• Execute and manage CAPA and NC investigations per procedures and quality-system requirements.
• Lead investigation activities from initiation to closure, including containment and corrective actions.
• Apply structured problem-solving and RCA to determine root causes and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users for objective evidence.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.

Skills

Communication skills

CAPA/NC processes

Quality investigation management

Evidence-based documentation

Cross-functional coordination

Experience in medical device industry

eQMS/ETQ familiarity

MS Office proficiency

Tools

ETQ eQMS

Microsoft Office Suite

Job description

REALIGN LLC in Irvine, CA seeks a CAPA/NC Investigator to lead quality investigations within the medical device quality system. You will drive containment, root-cause analysis, corrections, and preventive actions, ensuring evidence-based, traceable documentation.

You will coordinate with cross-functional teams, maintain timely records, and support regulatory or customer inspections with rigorous adherence to procedures and traceability.