QA/QC RA Manager, Electro Medical Devices, Vapi. ISO, CE

Job Description

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.