Posted:1 week ago|
Platform:
Work from Office
Full Time
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 systemsdevelopment, 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.
Larsen & Toubro (L&T)
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