Deep Enrich
Nidhi Malik
Product Engineer
3000 followers
Mumbai, Maharashtra, India
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About me
Quality Engineer II at Medtronic |PMP®|Lead Auditor ISO13485:2016|Lean Six Sigma yellow belt|DFSS Green belt|Internal Auditor ISO9001:2015|Operations Management
Education
University of Mumbai
2009 - 2013Bachelor's degree Biomedical/Medical Engineering First class with Distinction
Welingkar Institute of Management
2016 - 2018Post Graduate Diploma in Management Operations Management DistinctionUniversity of Mumbai
-Bachelor of Engineering - BE Biomedical/Medical Engineering
Experience
George philips medical engineering pvt ltd
Sept 2013 - Jul 2017Product EngineerI am responsible for product development and quality control of medical disposable products which are used in hospitals .Also I am responsible for internal auditing as per ISO 9001:2015 standards.Maintaining and designing Product SOP's,maintaining clean room standards,maintaining techinical files as per ISO 13485 standards.
Maestros Electronics and Telecommunications Systems Ltd
Sept 2017 - Sept 2018Regulatory Affairs Specialist
Cipla
Sept 2018 - Sept 2021Assistant Manager
Sept 2018 - Sept 2021Assistant Manager
Sept 2018 - Sept 2021
Medtronic
Sept 2021 - nowQuality Engineer II
Licenses & Certifications
ISO9001:2015 Internal Auditor
SGSAug 2015
Project Management Professional (PMP)
Project Management InstituteJul 2023
Lean Six Sigma Yellow Belt
MedtronicApr 2023
CQI and IRCA medical devices-Lead Auditor ISO 13485:2016
BSIAug 2022- View certificate
Generative AI Overview for Project Managers
Project Management InstituteDec 2024
- View certificate
Generative AI Overview for Project Managers
Project Management InstituteDec 2024 
Scrum Master Certified (SMC)
Scrum AllianceAug 2024DRM/DFSS Green belt
MedtronicJun 2023
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