Tejashri Sunil Mohite
Quality Assurance- Medical Devices & Pharmaceuticals
- Role
- Quality Engineer at Flex
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
Experience
Quality Engineer
Apr 2022 — Present · MX
Job Profile •Supporting America\'s site remotely with all available tools and providing efficient, timely and delighted service related to quality aspects within stipulated timely constraints.•Providing support related to review and documentation of assessment of suppliers.•Conducting Medical Skills Enhancement Training for all medical device regulations related topics.•KT Training to new joiners.•Creation & closure of the Customer Complaint into system and co-ordinating with the customer.•Review & compilation of productivity data. •Preparation of MIS for Front end team on weekly n monthly basis.•Implementation of revised Processes with related documents and records as per Change Management procedure involving Risk based approach.•Maintaining records of Monitoring & measuring devices & get it calibrated from time to time.•Responsible for validation & release work orders related to Calibration activities of Equipment’s.•Responsible for processing various Quality Oriented Reports with data from various Tools.•To carry out assessment of suppliers & approving them.•Responsible for processing various Quality Oriented Reports with data from various Tools.•Providing support for performing DHR related docs.•Performing review of in process E DHR.•Improvements in quality processes through Internal Kaizen Workshop (IKW).•Proficiently engaged with stakeholders to facilitate smooth project transitions, actively participating in discussion to understand needs and gather requirements effectively.•Successfully managed end to end project transitions encompassing both Quality and Engineering tasks, ensuring a seamless integration of processes and workflows.•Review & approval of Quality related docs.•Preparation & review of SOP,QC, FMEA & Control plan.• Performing Internal Audit at different sites.
Education
Vighnahartha Trusts Shivajirao S Jondhale College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2012 — 2016
Institue of Pharmaceutical Management
Post Graduate diploma in Regulatory Affairs, API & Formulation Regulatory Affairs
2016 — 2017
Bharati Vidyapeeth University College Of Engineering, Pune
Master of Business Administration - MBA, Production & operations management
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