Job Description

: Qualification: B.Tech / M. Tech in Bio-Medical Engineering from a reputed university. Salary: 40K to 50K Key Responsibility: \' Fulfilment of GMP and GLP compliance along with compliance of ISO 13485:2016 \' USFDA Regulation 510(K) Compliance as per 21CFR 821 \' CE Regulatory Compliance as per ISO 13485, application of CAPA for Continuous improvement. \' New Product Development Process \' Development of Surgical Techniques for various implants. \' Updating Company\'s Technical File, Clinical Evaluation Reports, Device Master File & Post Market Surveillance. \' Design Development concerns for Orthopedic implants along with its Technical Specification in compliance of ISO Standard. \' Developing testing methods, preparation of Standard testing procedures, Validation protocol and checking quality to ensure compliance \' Handling customer queries and ensuring customer satisfaction by providing effective services \' Preparation of various reports and technical documents like Risk Management, Design Dossier, ESR file & IDU (Instruction for use of product) etc. \' Developed and maintained product verification and testing documentation that was consistent with quality system regulation and compliant with ISO 13485 standards. \' Liaising for Collaboration between government research organization and company for new product development and to perform research work. \' Timely review for the batch production record and to ensure the compliance according to the QMS system \' Preparation of testing protocol for cost effectiveness along with QMS compliance \' Updating Quality Manual, Procedural Manual, MRM, Quality Objectives etc. \' Completion of Internal Audit and Supplier Audit onsite/ offsite both and approval of supplier based on supplier evaluation.

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