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Key Responsibilities:Management and control of document, Quality assurance procedure & SOPs. Control, Review and issuance of work instructions, SOPs, QSPs & artwork etc. Preparation and review of procedure, QSPs, qualification and validation protocol. Preparation and analysis of quality trends. Handling of change control management system and non-conformity of product. Conduct internal audit, supplier quality audit and support in external audit. Review of correction, corrective action and preventive action including effectiveness monitoring. Review and follow-up with internal department for external and internal calibrations as per schedule. Review/approve of proof check, print proof and artwork. Review the batch manufacturing Record. Provide training related to GMPs, QSPs, SOPs etc. Communicate and update the work instructions. Support in the investigation of non-conformity and market complaint. Collect the data for management review meeting & data analysis. Review of all quality test reports, printing specification and trends. Communicate and update the work instruction. Provide training to Microbiological procedure, GLP, QSPs, SOPs, GMP etc. Responsibility to review and release of batch release.Specific Skills Required:Technical files as per the requirement of EUMDR Preparing Technical files as per the requirement of MDD and ensure the compliance with the MDD requirements for class I, IIa, IIb and class III medical devices Preparation and review of Design History File, Clinical Evaluation Report, PMS Report, PSUR, PMCF report etc.