Manufacturing Quality Assurance Specialist
5 days ago
Job Description
">Responsibilities
The Validation Process Expert will be responsible for ensuring the quality and compliance of our manufacturing processes. This includes:
">- Performing gap assessments and conducting remediation of documents with stakeholder inputs.
- Supporting the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
- Creating/modifying process flows within the Manufacturing/Service Departments.
- Developing and maintaining Manufacturing/Service Work Instructions and related documents.
- Creating/modifying fixtures, tooling, equipment, and systems to support operations.
- Performing IQ, OQ, and PQ of fixtures, tooling, and equipment.
- Monitoring and driving corrective action, CAPA, and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
- Supporting corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Skills and Qualifications
">- Medical device experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.
- Ability to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment.
Our Company
">L&T Technology Services Limited is a leading provider of digital technology and engineering services. Our company values innovation, collaboration, and customer satisfaction.
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