Process Validation Engineer
2 weeks ago
Perform gap assessment and conduct remediation of documents with stakeholder inputs.
• Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices.
•Supports the development and introduction of new products, processes, and technologies, with focus on quality systems
development, regulatory compliance, and process risk management including pFMEA.
•Creation/modification of process flows within the Manufacturing/Service Departments.
• Development and maintenance Manufacturing/Service Work Instructions and related documents.
• Creation/modification of fixtures, tooling, equipment and systems to support operations.
• IQ, OQ, and PQ of fixtures, tooling, and equipment.
• Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.
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