Quality Systems Engineer

Katalyst CRO; Irvine (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CAPA investigations

Nonconformance investigations

Root-cause analysis

Quality-system documentation

Risk-based assessments

Cross-functional collaboration

eQMS proficiency

Ausbildung

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

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

Tools

eQMS

Jobbeschreibung

Job Summary

We are seeking a highly organized and detail-oriented Quality Systems Engineer to support quality system activities within a regulated medical-device environment. The ideal candidate will have hands-on experience with CAPA, Nonconformance (NC) investigations, root-cause analysis, corrective actions, and quality-system documentation.

• Manage and execute CAPA and Nonconformance (NC) investigation s in accordance with established procedures, quality-system requirements, and applicable medical-device regulations.
• Apply structured problem-solving and root-cause analysis methodologies to identify and address the underlying causes of quality issues.
• Conduct risk-based assessments and ensure investigation conclusions are supported by objective evidence, sound rationale, and appropriate documentation.
• Partner with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to collect evidence, resolve issues, and complete assigned actions.
• Facilitate investigation follow-up meetings and document decisions, action items, risks, dependencies, and escalations.
• Monitor and communicate investigation status, milestones, overdue actions, risks, and potential escalation requirements.
• Ensure CAPA, NC, and investigation records are accurate, complete, clear, timely, traceable, and inspection-ready.
• Track investigation milestones, action items, commitments, and due dates to support timely closure.
• Enter, update, review, route, and maintain quality records within the applicable electronic Quality Management System (eQMS).
• Support quality-system activities, documentation reviews, audits, and inspection-readiness initiatives.
• Maintain effective follow-up and coordination across multiple investigations and quality-system deliverables.
• Ensure activities are performed in compliance with company procedures, quality policies, and applicable regulatory requirements.
• Identify recurring quality issues, trends, and opportunities for process improvement and communicate findings to relevant stakeholders.
• Collaborate effectively with Quality, Manufacturing, Engineering, Operations, Regulatory, and other cross-functional teams.

Roles & Responsibilities

• Manage and execute CAPA and Nonconformance (NC) investigation s in accordance with established procedures, quality-system requirements, and applicable medical-device regulations.
• Apply structured problem-solving and root-cause analysis methodologies to identify and address the underlying causes of quality issues.
• Conduct risk-based assessments and ensure investigation conclusions are supported by objective evidence, sound rationale, and appropriate documentation.
• Partner with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to collect evidence, resolve issues, and complete assigned actions.
• Facilitate investigation follow-up meetings and document decisions, action items, risks, dependencies, and escalations.
• Monitor and communicate investigation status, milestones, overdue actions, risks, and potential escalation requirements.
• Ensure CAPA, NC, and investigation records are accurate, complete, clear, timely, traceable, and inspection-ready.
• Track investigation milestones, action items, commitments, and due dates to support timely closure.
• Enter, update, review, route, and maintain quality records within the applicable electronic Quality Management System (eQMS).
• Support quality-system activities, documentation reviews, audits, and inspection-readiness initiatives.
• Maintain effective follow-up and coordination across multiple investigations and quality-system deliverables.
• Ensure activities are performed in compliance with company procedures, quality policies, and applicable regulatory requirements.
• Identify recurring quality issues, trends, and opportunities for process improvement and communicate findings to relevant stakeholders.
• Collaborate effectively with Quality, Manufacturing, Engineering, Operations, Regulatory, and other cross-functional teams.

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• Preferred: Degree in Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering, or a related field.
• 3+ years of experience in Quality Engineering, Quality Systems, Quality Assurance, or a related role within the medical-device industry.
• Hands-on experience managing CAPA and Nonconformance (NC) investigations in a regulated environment.
• Demonstrated experience leading investigations through the complete lifecycle, including containment, issue definition/bounding, data collection, root-cause analysis, corrections, corrective actions, and closure.