
Dhiraj Deore
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About me
Specialist - Regulatory Affairs
Education

Vellore Institute of Technology
2013 - 2015Master of Technology (M.Tech.) CAD/CAM CGPA 9.07/10
Maharashtra Institute of Technology
2008 - 2012Bachelor of Engineering (B.E.) Mechanical Engineering First Class
Experience

Platinum Dies and Moulds
Nov 2014 - Jan 2015InternshipInjection Moulding Simulation Analysis and Optimization of Thermoplastic Part.

UPR ENGINEERING PRIVATE LIMITED
Mar 2016 - Sept 2017Engineer• Preparation of First Article Inspection Reports (FAIR) for customer approvals. (e.g., ROLLS ROYCE, TSAL, GE AVIATION, GODREJ & BOYCE, etc.)• Led and directed the Quality Department's daily activities, providing leadership, mentoring, and supervision of personnel.• Arranging resources in the inspection and quality areas to meet the production schedule.

Antolin
Sept 2017 - Nov 2019Quality Engineer• New parts development from concept to completion. • Prototype parts and tooled-up parts building and testing with quality confirmation. • Preparing PPAP documents and their timely submission to customers. • Developing an inspection system for new products. • Approving the checking of fixtures as per design and fitment with the help of CFT.• Conducting MSA and SPC studies as per drawing and customer requirements for critical characteristics.• Handling portable CMM machine (FARO ARM with LPP Probe) for inspection of checking fixtures and plastic parts.• GD&T / Engineering drawings. • APQP/PPAP/SPC/MSA. • RCA / 8D / 7QC. • DVP / CP. • Preparation of documents like PFMEA and CP. Mostrar menos

Tata Elxsi
Jan 2019 - now• Involved in gap assessment and remediation to establish compliance for EU MDR 2017/745.• Experienced in ISO 13485 (Quality Management Systems Standard) and ISO 14971 (Risk Management of Medical Devices Standard). • Identifying product-specific and applicable standards and ensuring the product meets the compliance requirements.• Creation of new technical files such as product descriptions, general safety and performance requirements, product risk analysis, CMR forms, List of applied standards, Verification and Validation rationale, predecessor and competitor device documents, and Biocompatibility reports.• Experienced in executing Design verification plans and reports of Medical devices.• Assessment of available test plans and test reports and check for compliance with the requirements/standards.• Reviewed the deficiency report received from the notified body, sorted out accepted deficiencies, and updated them in the Submitted file.• Good knowledge of the design control process and participation in design inputs, outputs, verification, and validation activities.• Experienced in preparing General Safety and Performance Requirements (GSPR). Mostrar menos
Specialist
Jul 2024 - nowSenior Engineer
Jan 2019 - Jun 2024
Licenses & Certifications
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Autodesk Simulation MoldFlow Advisor
Milestone Plm Solutions Pvt Ltd-Vasai (W)Feb 2015- View certificate

AMCAT Certified Data Processing Specialist
Aspiring MindsSept 2014 
Business Pro+ Intermediate
YzerlyNov 2023
Languages
- enEnglish
- hiHindi
- maMarathi
- taTamil
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