 Experience in Medical device EU MDR compliance activities and performing gap assessment for MDD to MDR. Risk management file preparation, review and update. Design control activities like design verification and validation testing protocol and report preparation and review. New product development design phase gate review and action follow up. BOM update with respect CCP. Design history file preparation. Implementation of engineering change request (ECR & ECN). Compilation of complaint data and preparation of PMS file. Review of General safety and performance requirements. Label redlines activities accordance with ISO15223-1 and EU MDR requirements. Consolidated technical documentation and support regulatory affairs for submitting the STeD and regulatory documents to Notified body. Implementation of procedure pack in the EU region. Review of PPAP documentation. Handling of customer complaints and CAPA verification and effectiveness monitoring. Performing internal audit. Creating and maintaining of quality system documents in accordance with ISO 13485 system Requirements Familiar in SAP, MasterControl and JDE database.

 Experience in handling of customer complaint with suitable problem solving technique. Prepare monthly In-house Rejection/Rework and customer complaint report, graphical trends communicate to all process owner. Conducting weekly customer complaint, rework review meeting and follow up of action plan and verify the implementation status and effectiveness monitoring of Corrective action. Preparation of PPAP documentation.  Participating new product review meeting and making correction of documents such as SOP, Engineering change request with respect to Technical specification.  Experience in preparing, Implementation and maintaining a quality documents of ISO 9001, 14001 and 45001standard requirements. Interact with various department personnel’s and observe the existing process to prepare departmental procedures based on quality standards requirements. Experience in Process audit, Product audit, Inward inspection, Final inspection, Team Management and Quality control documentation works. Plan, organize, perform and evaluate the Internal Quality audit (IQA) and Management review meeting (MRM). Typically generate and distributes the report to concern department and follow-up the action plan and closure. Co-ordinate with External Auditor & Certification body for auditing of certified standards.

 Implementation of ISO 16949 system in the organization. Performed as a management representative to collect all KPI from respective domain and share to management. Addressing the Customer complaints in register and communicate to all level in an organization, control of documented information Customer complaint handling and quality engineering and quality system maintenance activities. Planning of changes and risk management. Support to internal and external audit. New product development and implementation of engineering release note against customer complaints corrective action. Controlled and maintained the quality system manuals and procedure.

 Performed inprocess inspection in steering knuckle product line. Supported to internal and external audits. Measurement system calibration details verification activity. SPC follow up and final quality inspection