Quality Assurance Executive

Job Description

To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including- Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc. Fulfilment of regulatory requirements related to EC directive, various Govt. tenders & registration of overseas. Follow up of local regulatory & drugs requirements. Validation- machines, processes, clean rooms, material & sterilization. Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports. Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall. MRM- Organizing & follow up actions from previous meetings. Review & modification in all the SOPs & manuals. Master list of records- Establishment & updating. Master list of documents- Establishment & updating. Deviations- Follow up & records Corrective & preventive actions- Corrections, implementations & maintenance. Calibration of equipment and machines of production & quality control. Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies. Training- Planning & Imparting Requirements: Work experience should be minimum 3-4 years in medical devices manufacturing. Excellent computer skills Goal Oriented Strong communication skills, including the ability to explain and teach methodologies Understanding of manufacturing methods and quality standards A confident and determined approach Excellent organizational & time management skills Team player Interested candidates can send their updated resume (hr at madhuinstruments.com) or can call 8130384348 Job Type: Full-time Pay: ₹35,000.00 - ₹45,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person