Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.
The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.
Roles & Responsibilities:
Monitor manufacturing processes to ensure product quality and compliance with defined standards.
Manage non-conformances (Client), deviations, and CAPA activities.
Perform root cause analysis (RCA) and implement corrective and preventive actions.
Support internal and external audits (FDA, ISO).
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
Drive continuous improvement initiatives using Lean Six Sigma methodologies.
Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
Ensure proper documentation and traceability of manufacturing and quality records.
Education & Experience:
Bachelor's degree in Engineering or a related field.
Experience in medical device manufacturing preferred.
Strong understanding of regulatory and quality systems.
Good communication and cross-functional collaboration skills.
Manufacturing Quality.
GMP.
ISO 13485.
FDA 21 CFR Part 820.
CAPA.
Client.
Root Cause Analysis (RCA).
Risk Management (FMEA).
Statistical Process Control (SPC).
Audit Compliance.
Quality Management System (QMS).
Continuous Improvement.
Numbers & Facts
Location
Northridge, CA
Skills
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentationunmatched
Environmental Monitoringunmatched
External Auditunmatched
FDA (Food and Drug Administration)unmatched
Failure Mode and Effects Analysis (FMEA)unmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Lean Manufacturingunmatched
Lean Six Sigmaunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Process Manufacturingunmatched
Process Validationunmatched
Production Controlunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Standards Developmentunmatched
Statistical Process Controlunmatched
Systems Administration/Managementunmatched
Systems Maintenanceunmatched
Team Playerunmatched
Traceabilityunmatched
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