Quality Systems Engineer

Katalyst Healthcares & Life Sciences

Irvine, CA

Instant Apply

30+ days ago

Job Description

Job Description:

We are seeking a 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 documentation.
The candidate should be highly organized, detail-oriented, and capable of managing multiple investigations and quality-system deliverables while collaborating effectively with cross-functional stakeholders.

Responsibilities:

Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements.
Lead investigations from initiation through closure, including:
Immediate containment.
Issue/problem definition and bounding.
Data collection.
Root-cause analysis.
Corrections.
Corrective actions.
Effectiveness planning, where applicable.
Apply structured problem-solving and root-cause analysis methodologies to determine the causes of quality issues.
Support risk-based decision-making and ensure appropriate documentation of investigation conclusions.
Coordinate with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to obtain objective evidence and complete assigned actions.
Facilitate investigation follow-up meetings and document decisions, action items, risks, and escalations.
Proactively communicate investigation status, delays, risks, and potential escalation requirements.
Ensure investigation records are accurate, clear, complete, timely, traceable, and supported by appropriate evidence and rationale.
Track CAPA, NC, and investigation milestones and maintain visibility of open actions through timely closure.
Enter, update, route, and maintain quality records in the applicable electronic Quality Management System (eQMS).
Support quality-system activities and ensure documentation is inspection-ready.
Maintain strong follow-up and coordination across multiple quality-system activities.
Ensure compliance with applicable company procedures and regulatory requirements.
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline

Must-Have Technical / Functional Skills:

Strong written and verbal communication skills with the ability to clearly document and present investigation outcomes.
Previous experience in the medical device industry.
Working knowledge of CAPA and Nonconformance (NC) processes.
Hands-on experience managing quality investigations, including:
Containment
Issue bounding
Root-cause analysis
Corrections
Corrective actions
Ability to develop clear, objective, evidence-based investigation documentation.
Strong organizational and follow-up skills.

Numbers & Facts

Location

Irvine, CA

Skills

Biologyunmatched
Communication Skillsunmatched
Corporate Complianceunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Collectionunmatched
Detail Orientedunmatched
Documentationunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Record Keepingunmatched
Regulatory Requirementsunmatched
Riskunmatched
Root Cause Analysisunmatched
Systems Engineeringunmatched
Time Managementunmatched
Writing Skillsunmatched

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