Job Title

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.