Quality Systems Engineer: CAPA & NC Investigator

Creative Solutions Services, LLC; Atlanta (GA); On-site; USD 85,000 - 105,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a highly organized Quality Systems Engineer to support CAPA, NC investigations, root-cause analysis, and quality-system documentation in a regulated medical-device environment. You will partner with cross-functional teams to collect evidence, resolve issues, and ensure compliant investigations end-to-end.

The role requires hands-on CAPA/NC investigations, risk-based assessments, and maintaining inspection-ready records within an eQMS.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical field.
• 3+ years in Quality Engineering or Quality Systems within medical-device industry.
• Hands-on CAPA and Nonconformance investigations in regulated environments.
• Experience leading investigations through containment, data collection, root-cause analysis, corrections, corrective actions, and closure.

Responsibilities

• Manage and execute CAPA and Nonconformance investigations per procedures and medical-device regulations.
• Apply structured problem-solving and root-cause methodologies to address quality issues.
• Conduct risk-based assessments with evidence-backed conclusions and documentation.
• Collaborate with investigation owners, process owners, SMEs, and cross-functional stakeholders to gather evidence and complete actions.
• Facilitate investigation follow-up meetings and document decisions, actions, risks, and escalations.
• Monitor status, milestones, overdue actions, risks, and escalation needs.
• Ensure records are accurate, complete, and inspection-ready in the eQMS.
• Track milestones and due dates to support timely closure.
• Maintain quality records in the eQMS and support audits and inspections.

Skills

CAPA investigations

Nonconformance investigations

Root-cause analysis

Risk-based assessments

Quality-system documentation

eQMS familiarity

Education

Bachelor's degree in Engineering, Life Sciences, or Quality

Preferred: Biomedical/Mechanical/Electrical/Industrial Eng

Job description

Creative Solutions Services, LLC is seeking a highly organized Quality Systems Engineer to support CAPA, NC investigations, root-cause analysis, and quality-system documentation in a regulated medical-device environment. You will partner with cross-functional teams to collect evidence, resolve issues, and ensure compliant investigations end-to-end.

The role requires hands-on CAPA/NC investigations, risk-based assessments, and maintaining inspection-ready records within an eQMS.