Surya Teja Batchu Email & Phone Number

Warsaw, In, Us

New Brunswick, New Jersey, Us

• Responsible for reviewing of manufacturing process, validation reports (IQ, OQ and PQ) using Windchill software (EDMS).• Responsible for reviewing Process development on Manufacturing environment.• Responsibilities include work on product flow processes, Gage R&R, manufacturing operations, establishing process methods which meet performance and quality requirements.• Responsible for reviewing changes in manufacturing operations to be compliance with quality standards to meet FDA requirements.• Review the created and red lined existing documents (i-criterias or control charts) and approve to new version using Windchill software.• Responsible for reviewing risk management activities, update dFMEA, pFMEA's, etc.• Responsible for reviewing update of forms, clip IFU’s and work instructions, etc• Critical to Quality (CTQ) analysis, Reviewing BOM and routers.• Responsible for changing sampling plan on i-criteria files from minimum level of inspection (AQL Level) to 100% for the features which are identified as CTQ’ for those parts in the scope of project as per company requirements.• Reviewing Non-Change Control Change Notices (CN) on Windchill (EDMS) for required project deliverables.• Reviewing and approving Supplier made products with suppliers, by following required compliance documentation as per SOP’s (Standard Operating Procedures) and WI’s (Work Instructions) of company to meet FDA standards.• Responsible for statistical and capability analysis using SOP’s (Standard Operating Procedures) as reference for validation requirements.

New Brunswick, New Jersey, Us

• Responsible for reviewing of manufacturing process, validation reports (IQ, OQ and PQ) using Adaptiv software (EDMS).• Responsible for Manufacturing engineering services which includes process development, etc.• Responsibilities include work on manufacturing operations, establishing process methods which meet performance and quality requirements.• Review the created and red lined existing documents (i-criterias or control charts and clip IFU’S) and approve to new version using Adaptiv software.• Responsible for reviewing update of forms, clip IFU’s (Chinese and Japanese) and work instructions, etc• Collaborated with cross functional departments (Manufacturing and Regulatory) to balance production and validations.• Got trained on required transition of EDMS from Adaptiv to Windchill as per organizational needs.• Routed Non-Change Control Change Notices (CN) on Windchill (EDMS) for required project deliverables. • Following all cGxP standards to meet FDA regulations as per 21 CFR Part 820, ISO 13485, ISO 14971.

Warsaw, Indiana, Us

• Responsible for manufacturing process of Microfix parts by checking features of product by validating (IQ, OQ and PQ) using InfoPV software (EDMS). (Class III devices)• Updating MC’s (Manufacturing Change) with respect to inspection criteria number of SKU’s and sorting SKU’s accordingly.• Responsible for Manufacturing engineering services which includes process development, etc.• Responsibilities include work on manufacturing operations, establishing process methods which meet performance and quality requirements.• Create and red line existing documents (i-criterias), and update to new version using Change Management System (CMS) as a part of CAPA (Corrective Action and Preventive Action) project.• Responsible for update of forms and work instructions• Validation of protocol and execute them.• Critical to Quality (CTQ) analysis, Updating BOM and routers.

Warsaw, Indiana, Us

• Authored Technical files based on the router information for Class I and Class II Reusable Surgical Instruments as per new EU-MDR (2017/745) guidelines.• Updating existing Router information for the scope of Reusable Surgical Instruments based on the changes affecting their use with the new EUR MDR guidelines as compared to the previous EU MDD guidelines using JD Edwards ERP software.• Creating data to build routing information by pulling it from XA with help of MS Access.• Reviewing the Routing operations, Item revisions, Item processes, Manufacturing Order (MO) history, BOM’s on XA with product and router ID.

Warsaw, Indiana, Us

• Responsible for all validation requirements including DOE.• Involved in development and execute Validation protocols (IQ, OQ, and PQ) and reports using InfoPV software (EDMS).• Train employees on proper machine operations, procedures, and cleanroom practices.• Performed statistical Data Analysis Experience using Minitab.• Estimated good PpK values so that there is a good seal strength of the material during OQ and PQ parameters with its respective reliability and confidence values.• Performed validations in ISO 14644-1 Cleanroom Standards of class ISO 8.• Strong knowledge about Medical device regulations like FDA: 21 CFR Part 11 and 21 CFR Part 820, ISO 13485, ISO 14971 and other domestic and international regulations.• Executed and validated 90% of tray models associated with packaging department which can have sealed them with obtained parameters from execution unless there is a change in the material of trays.• Collaborated with cross functional departments to balance production and validations of our team.• Strong knowledge about Medical device regulations like 21 CFR Part 820, ISO 11607-02, and other domestic and international regulations.

Warsaw, Indiana, Us

• Experienced in Design Controls, MDR, DHF master remediation, Hazard Analysis, dFMEA, uFMEA, Master Trace Matrix, Verification, and Validation Test protocols and reports.• Reviewed User needs, Design Inputs and Design Interactions of various products. • Verified the accuracy of task analysis and use scenario and checked whether they are meeting with user needs (Surgeons).• Accomplished Stage 1 design review which covers; User Needs, Design Inputs & Interactions, User Analysis, Task Analysis and Use Scenario.• Reviewed Geometric Evaluations and Tolerance Analysis protocol and report documents for quality check with respective to DI’s and Acceptance Criteria.• Performed quality check on dFMEA and uFMEA and analyzed the hazard situations, harms and failure modes associated with them.• Created Risk Control Measures (RCM) on EDMS, root cause analysis to predict 95% of Failure Modes (FM) of product and its function with the help of development engineers.• Worked through stage 3&4, which helped to review verification and validation protocols and linked up these reports to uFMEA and dFMEA.• Worked on CTQ and Product Specifications to evaluate its severity level and determining the product would be essential or non-essential.• Worked on Master Trace and performed quality check whether Design Inputs and Interactions are linked up to appropriate RCM and user needs. Especially which are known as essential.• Applied Design Control procedures that comply with requirements of 21 CFR Part 820 Quality System Regulations.• Handled 60% of DHF in our department and worked with development and cross-functional teams to remediate about 15 year’s worth of information.

Mumbai, Maharashtra, In

• Organized and monitored equipment used in various stages of manufacturing and assembling process of heavy automotive.• Categorized assembling equipment by assigning unique Asset Serial Numbers to each tool based upon the processing stage and the compatible machines.• Worked on Inventory management by creating schedules, monitoring stock levels at the warehouse and replenish stock whenever necessary.• Gained immense practical knowledge of manufacturing and assembling processes of heavy-duty vehicles along with firsthand experience in various types of manufacturing systems such as Mass production and batch production.• Developed Macros to get the status of equipment on the floor and store to get alerts when the stock in stockroom gets below the required quantity via text or email.

London, Gb

• Analyze the work content of the operator.• Gained assistance in Preparation of Line Plan, process stabilization and standardization and in modifications of the layout to meet target capacity.• Involved in Continual improvement projects focusing on Productivity, Quality & cost.• Ergonomic Analysis for the operator & designing the workstation using MAPS.• Gained knowledge in how to Fix production norms, Time estimation, Method studies, Line balancing & Manpower planning as per monthly plan.

Master Of Business Administration - Mba, Business Administration And Management, General

Master'S Degree, Engineering/Industrial Management

Bachelor'S Degree, Automotive Engineering Technology/Technician