Summary:
In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards.
Roles & Responsibilities:
Develop and execute validation plans and reports.
Analyze data and troubleshoot process deviations.
Ensure compliance with FDA regulations and ISO standards.
Collaborate with Engineering and Quality teams to drive continuous improvement.
Required Qualifications:
8+ years of validation experience in the medical device or other regulated industry.
Strong expertise in injection molding and plastic materials.
Hands-on experience with cleaning validation and contamination control.
Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
Numbers & Facts
Location
San Jose, CA
Skills
Code of Federal Regulationsunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Analysisunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Maintain Complianceunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Plastic Injection Moldingunmatched
Process Improvementunmatched
Process Validationunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Statisticsunmatched
Validation Documentationunmatched
Validation Planunmatched
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