Rasmi Ranjan Sahoo

• Creating Supplier Quality Agreements as per requirement of customer standard and EN ISO 13485:2016
• Supporting worldwide customers (Overall GEO) and leading team of 8 members
• Negotiating with the supplier for Supplier Quality Requirements
• Updating the requirement of Supplier quality agreement as per revision of standard
• Supporting the Audits from different notified bodies (BSI, TUV, MDSAP etc.)
• Updating the gap assessments for different quality agreement and initiating the remediation of supplier quality agreements
• Completed 10 supplier quality CAPA's with more than 100 suppliers each
• Additional responsibility: Performing the responsibility as Project Quality Analyst and Defect preventive Analyst.

• Design, Detailing and Drawing Review of medical devices, tools and fixtures using NX 8.5, ADAPTIV and Team center
• Created Tool drawing, Tool assemblies with proper GD&T for different manufacturing process for orthopedic implants as per Customer specified standard
• Created legacy changing drawing for different orthopedic products like implants and instruments
• Created on DHF (Design history file) which include validation documents like IQ, OQ, PQ, RA by coordinating with onsite co-coordinators and customer
• Updating & correcting the ECA/ ECO& BOM on regular basis
• Generating and recording the new drawing Specification and part number in ADAPTIVPLM
• Additional responsibility: Performed the responsibility as Defect preventive Analyst and Configuration Controller.

· Design, Detailing and Drawing Review of medical devices using NX 8.5, ADAPTIV and Team Centre.

· Created Digital X-Ray templates for different kind of orthopedic implants.

• Created and released the specification drawings in PLM system with the customer’s approval.
• Created the Supplier Qualification Strategy and Supplier Qualification Agreement documents by coordinating with onsite resource and supplier of the client/customer
• Created the Inspection report of the parts in a particular new product
• Created the DFMEA documents for the products as per the EN ISO 14971:2012
standard.
• Updating & correcting the ECA/ ECO& BOM on regular basis
• Generating and recording the new drawing Specification and part number in
ADAPTIVPLM.
• Created Usability Engineering report for different medical devices under IEC 62366, complaint analysis for medical devices.
• Analysis of different shelf-life testing reports for medical devices and PLM like Adaptive.
• Tol stack analysis for the medical devices and verification and validation activities for medical devices.