Quality Systems Engineer - CAPA & Investigations Lead

JobDiva, Inc.; Irvine (CA); On-site; USD 95,000 - 135,000; Full time

Job summary

JobDiva, Inc. in Irvine, CA is seeking a Quality Systems Engineer to support quality-system activities in a regulated medical-device environment. You will manage CAPA, NC investigations, and documentation.

The role requires strong problem-solving, data collection, containment, root-cause analysis, and effective communication with stakeholders. Bachelor’s degree in Engineering or Life Sciences is required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Hands-on experience with CAPA and Nonconformance (NC) processes.
• Experience in the medical device industry.
• Ability to develop objective, evidence-based investigation documentation.
• Strong written and verbal communication and organizational skills.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures.
• Lead investigations from initiation through closure with containment, data collection and root-cause analysis.
• Prepare corrective actions and effectiveness planning.
• Maintain quality records in the eQMS and ensure documentation is inspection-ready.
• Coordinate with owners and stakeholders to obtain evidence and close actions.
• Communicate investigation status, risks, and escalation needs.

Skills

CAPA management

Nonconformance investigations

Root-cause analysis

Quality documentation

Data collection

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

eQMS software

Job description

JobDiva, Inc. in Irvine, CA is seeking a Quality Systems Engineer to support quality-system activities in a regulated medical-device environment. You will manage CAPA, NC investigations, and documentation.

The role requires strong problem-solving, data collection, containment, root-cause analysis, and effective communication with stakeholders. Bachelor’s degree in Engineering or Life Sciences is required.