Smit Shah

Experience

• 

  Mediscient Devices Pvt. Ltd.

  May 2021 - Jul 2023

  - Conducted machine validation (DQ, FAT, IQ, OQ, PQ) for 5+ PLC-operated assembly machines and 3 production machines, improving process efficiency by 41.67%.- Administered QMS per ISO 13485, MDSAP, and FDA QSR across 4+ regulatory frameworks (EU MDR, CMDR, FDA).- Directed 4 internal audits and 5 supplier audits, ensuring 100% closure of audit findings within timelines and reducing non-conformities by 30%.- Performed 50+ inspections (incoming, in-process, pre-dispatch) for Class II medical devices.- Resolved 10+ production issues through design modifications in SolidWorks.- Carried out root cause analysis for 7+ quality issues using the 5 Whys method, leading to corrective actions.- Executed deviation investigations and implemented CAPA for resolving 6 + non-conformance issues, improving product quality and compliance with regulatory standards.- Authored 20+ SOPs, 50+ Work Instructions, and 50+ quality protocols, ensuring comprehensive regulatory documentation.- Led risk management per ISO 14971, mitigating 95% of identified risks through dFMEA, pFMEA, and control plans.- Spearheaded supplier quality initiatives, qualifying 6 vendors and maintaining compliance with ISO 13485.- Facilitated 15+ training programs for quality inspectors, engineers, and designers, achieving an average exam score of 93%.- Delivered packaging, transit, and performance testing for NSD and InsuPress, ensuring regulatory compliance.- Developed and maintained technical documentation for 3 medical devices, ensuring complete documentation for regulatory submissions, including compliance with FDA, EU MDR, and Health Canada requirements.- Validated 50+ 3D-printed prototype parts for functionality and suitability, providing valuable insights for product development and iteration.- Key Projects: Needle Safety Device ( Lanreotide Device ) - 2, Fixject – Fix Dose Insulin Pen, Insupress – Smart Wearable Insulin Pen, Needle Safety Device ( Lanreotide Device ) - 1 Show less - Enhanced daily production workflows by optimizing processes for Class II medical devices, achieving a 10% increase in output while maintaining ISO 13485 compliance.- Reduced prototyping costs by 15% through efficient use of SLA and FDM 3D printing technologies, improving the precision of medical device components.- Supported product design and risk analysis for the Fix-Dose Insulin Pen and Needle Safety Device, resulting in 100% alignment with FDA and EU MDR requirements.- Improved product functionality and manufacturability by collaborating on design modifications, achieving a 20% improvement in component reliability during testing. Show less

  • Quality Engineer

    Dec 2021 - Jul 2023

  • Intern

    May 2021 - Nov 2021
• 

  Mediscient Devices Pvt. Ltd.

  Sept 2023 - Feb 2024

  Quality Engineer

  - Managed and maintained the risk management file, revising risk management SOPs and methodologies per customer requirements. Addressed NSD-2 non-conformances and resolved customer complaints, ensuring compliance. Supported machine validation for NSD-2, enhancing process reliability.- Assisted in preparing regulatory documentation and risk analyses for NSD-2 device to meet FDA & EU MDR compliance.- Drafted 6+ SOPs, 15+ Work Instructions, and 20+ Quality Protocols to ensure regulatory compliance.- Reviewed audit findings reports and resolved 100% of non-conformances related to NSD -2 machine validation.- Examined functional and performance testing for the NSD-2 device, benchmarking against the Reference Listed Device (RLD) to ensure 100% compliance with design specifications and enhance product reliability. Show less