Quality Systems Engineer: CAPA & NC Investigations

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks a Quality Systems Engineer to support CAPA, NC investigations, root-cause analysis, and quality-system documentation in a regulated medical-device environment. You will apply structured problem-solving, conduct risk-based assessments, and ensure investigation conclusions are supported by evidence and proper documentation.

Collaborating with Quality, Manufacturing, Engineering, Operations, and Regulatory teams, you will maintain accurate eQMS records, track milestones, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• 3+ years of experience in Quality Engineering, Quality Systems, or related role within the medical-device industry.
• Hands-on experience managing CAPA and Nonconformance investigations in a regulated environment.
• Experience leading investigations through containment, issue definition/bounding, data collection, root-cause analysis, corrections, corrective actions, and closure.

Responsibilities

• Manage and execute CAPA and NC investigations per procedures and medical-device regulations.
• Apply structured problem-solving and root-cause analysis to identify root causes.
• Perform risk-based assessments and document conclusions with evidence.
• Collaborate with owners, SMEs, and cross-functional teams to resolve issues and complete actions.
• Enter and maintain quality records in the eQMS and support audits and inspection-readiness initiatives.
• Monitor investigation milestones and ensure timely closure.

Skills

CAPA investigations

Nonconformance investigations

Root-cause analysis

Quality-system documentation

Risk-based assessments

Cross-functional collaboration

eQMS proficiency

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline

Preferred Biomedical/Mechanical/Electrical/Chemical/Industrial Engineering or related field

Tools

eQMS

Job description

Katalyst CRO seeks a Quality Systems Engineer to support CAPA, NC investigations, root-cause analysis, and quality-system documentation in a regulated medical-device environment. You will apply structured problem-solving, conduct risk-based assessments, and ensure investigation conclusions are supported by evidence and proper documentation.

Collaborating with Quality, Manufacturing, Engineering, Operations, and Regulatory teams, you will maintain accurate eQMS records, track milestones, and