Quality Assurance Specialist
2 days ago
Futran Tech Solutions Pvt. Ltd. is seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will be responsible for contributing to continuous improvements in overall product cost and quality.
Key Responsibilities:- Contribute to the development and implementation of quality improvement initiatives to reduce costs and improve product quality.
- Participate in Design for Manufacturing (DFM) and Design for Assembly (DFA) activities to ensure that packaging and production processes and equipment are optimized.
- Collaborate with Quality Engineering teams to provide manufacturing support and ensure compliance with regulatory requirements.
- Create standardized work and process maps to optimize production systems and extended value streams.
- Support line validation and qualification activities, including IQ, OQ, MSA, and PQ.
- Perform root cause analysis, NCR, and CAPA responses to identify and resolve quality issues.
- Conduct qualification, verification, and validation activities to ensure the production of medical devices meets regulatory requirements.
- Work with cross-functional teams to troubleshoot problems on the production floor and implement corrective actions.
- Design, develop, test, and validate equipment and processes, and analyze and interpret process models to recommend process improvements.
- Drive the execution of validation and PFMEA activities as per the project plan.
- Apply statistical and analytical methods, such as SPC, SQC, and DOE, to analyze and improve processes.
- Contribute to the Capital Expense Request (CER) process, specifying costs for packaging, labeling, and sealing equipment while considering product standard cost targets and capacity demands.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCRs, and CAPAs.
- Execute site acceptance tests and factory acceptance tests based on North Haven requirements.
- Execute validation gap analyses of various product families based in Medtronic.
- Plan and initiate CDPs associated with validation activities.
- Coordinate with stakeholders to ensure effective communication and collaboration.
Futran Tech Solutions Pvt. Ltd. offers a dynamic and challenging work environment with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality and process improvement, we encourage you to apply for this exciting opportunity.
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