Sujin Katta

Company Overview: B. Braun is one of the world’s leading providers of healthcare products today; the company’s operations are organized into four divisions: Hospital Care, Aesculap, Outpatient Market, and Avitam.

• Design reviews associated with user needs, design inputs, design outputs, risks, design validation, and verification.
• Maintains and updates the Design History File & Device Master Record as appropriate - PMS, Clinical results etc.
• Drafting Design verification plans, Design verification protocols, reports & Design & Development plans.
• Leads quality related problem solving, root cause analysis, FMEA during design and manufacturing.
• Development and supports of Validation master plans, defining validation strategy, sampling requirements for validations and process validation requirements – URS, FAT, SAT, PFMEA, DQ, IQ, OQ & PQ and Final recipes.
• Responsible for Prospective & Re-validations of Injection molding, Extrusion, Packaging, assembling machines, Sterilization, ultrasonic welding, and special purpose machines.
• Supplier Qualification: Leads Product and Process Qualification of suppliers providing components/systems (Goods / Services) – Machining, plastic injection moldings, extrusion, Castings, forgings, Heat treatment, sterilization, semi-finished goods chemicals, and other raw materials.
• Supplier Qualification – support on-boarding of new suppliers by performing supplier capability analysis and assessment of supplier risk.
• Supplier audits, self-questionnaire, first sample testing, provides specifications, confirmation of specification, Performance monitoring, non-disclosure agreements (NDA) and conclusion of Quality Assurance Agreements.
• Supports Supplier risk management methodologies and Root cause analysis, CAPA Measures, notifications for Supplier quality issues.
• QMS & MDR: Experience in Document control for organization and ensure that maintaining the quality documents and Good Documentation practices throughout the organization, Creation of Quality manual, Quality system procedures as per ISO 13485:2016 for organization.
• Review to ensure the correctness of the production system and its documentation.
• Experience in the development of test method developments, test method validations, and verifications.
• Responsible for the calibration of tools and measuring devices at internal as well as external sources.
• Supports the preparation of risk management files – product, process, and equipment risk analysis as per 14971.
• Preparation of EU-MDR technical documentation – MDR classification, device description, GSPR, benefit-risk analysis, design, and manufacturing information.
• Medical device classification, risk classification, information on the label, implementation of UDI (PI and DI).
• Conducting transport simulations, Mock recalls, and develops new packaging configurations as per 11607:2019.
• Coordinating with external testing facilities for Bio compatibility studies, Sterility testing.
• Verifies /Reviews the PMS protocols and PSUR, PMCF Reports, Clinical Evaluation reports.
• Responsible for IPQA team, identifying the skill gaps of all Quality team and train them accordingly.
• Coordination with Global teams for to get understanding of business needs for the project transfer activities.
• Responsible for final release of finished goods & Maintains Device History Record (DHR or BMR).
• Extensive exposure on Track wise – CAPA & Deviation Handling.
• Knowledge about preparing SOPs, work instructions, and change management. Process, Engineering, Raw material.

Company Overview: Vasantha Tool Crafts Pvt Ltd, Hyderabad, an ISO 9001:2015 (TUV-SUD) company, state-of-the-art tool room, has successfully executed more than 5,000 injection molding tools. Design & manufactures of mechanical components and Injection Moulds for complex Plastic and metal Components for packaging, Electrical, Medical, Automotive, Household crafts etc.

• Good knowledge about manufacturing processes/technologies: conventional, CNC milling, turning, EDM, wire EDM, direct metal laser sintering (additive manufacturing), heat treatment, CG, and SG grinding, etc.
• Quality inspection planning of all machining products and plastic components, CMM inspection management, review reports, inspector skill enhancement, and team development.
• Coordinate External certification, Re-certification, New certification, Surveillance audits and customer audits.
• Knowledge and Experience in preparing of the Quality plans, Internal Audit schedules & Support the team to maintain control documents.
• Actively participate and contribute to External/Internal audits.
• Expert in managing Customer complaint through RCA, Effective CAPA, and Closure of customer complaints & Hosts periodic customer visits.
• Listing of new Equipment, new Tooling, new Manufacturing Fixture and new facility requirements.
• To make CMM (Zeiss-Calypso) 2D &3D programs from CAD models using 5Axis Technology for conducting regular Inspection of complicated machining operations.
• Strong Programming, Debugging, executing skills, Cycle Optimization addressing customer issues & NPD (New product Development) CMM programming.
• Hands on Experience with all types measuring instruments and Inspection methods.
• Good knowledge on IMEA Requirements & Priorities.
• Non-Destructive Tests (ultrasonic, pressure and leak tests, dye penetrant tests, etc.) for detecting cracks on metals & welded joints.
• Responsible for the calibration of instruments (AMC) and gauges before their due date.

Company Overview: EPE has been awarded with ISO 9001:2008 certifications by Bureau VERITAS for Design, manufacture and supply of Bladder, Diaphragm and piston type Hydro-pneumatic Accumulators, Industrial filters &Filter Elements.

• Inspection of incoming, in-process, and final inspections for the CNC-manufactured parts, and preparation of inspection reports.
• Testing and monitoring the results of Hardness Tester, Roughness tester, Tensile & shear for Diaphragms.
• Knowledge about all the measuring instruments, like Vernier, micrometer, bore gauge, dial gauge, thickness gauge, air gauge, CMM, etc.
• Supports the internal, external, and vendor audits, and follows up on the closure of audit points.
• Maintain all the records and documents as per ISO standards.
• Receiving and posting the inspection activities through SAP.