Quality Systems Engineer - CAPA & Investigations (Onsite Irvine)

Acestack; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Acestack is seeking a Quality Systems Engineer to join our Irvine, CA team. This onsite, full-time role focuses on leading CAPA and Nonconformance investigations in a medical device environment, with emphasis on containment, data collection, root-cause analysis, and corrective actions.

The ideal candidate has hands-on experience with CAPA/NC processes, strong documentation, and the ability to coordinate with cross-functional teams to ensure investigation closure and regulatory readiness.

Qualifications

• Experience in medical device quality systems.
• CAPA/NC investigation experience.
• Strong documentation, recording, and traceability skills.
• Ability to lead investigations from initiation to closure with evidence-based conclusions.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures.
• Lead investigations from initiation through containment, data collection, root cause analysis, and corrective actions.
• Apply problem-solving methods to determine causes of quality issues and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users to obtain objective evidence.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.
• Maintain accurate quality records in the eQMS and support audits and inspections.

Skills

CAPA/NC processes

Quality investigations

Structured problem solving

Cross-functional coordination

Documentation & traceability

Tools

ETQ

MS Office

Job description

Acestack is seeking a Quality Systems Engineer to join our Irvine, CA team. This onsite, full-time role focuses on leading CAPA and Nonconformance investigations in a medical device environment, with emphasis on containment, data collection, root-cause analysis, and corrective actions.

The ideal candidate has hands-on experience with CAPA/NC processes, strong documentation, and the ability to coordinate with cross-functional teams to ensure investigation closure and regulatory readiness.