Walk-in || Assistant Manager / Sr. Engineer - Quality Assurance
Polymede · Faridabad · onsite · Posted 42d ago
About a minute. You'll make an account on the way through.
About this role
Role & responsibilities
- PREPARE, REVIEW, AND UPDATE TECHNICAL DOCUMENTATION, INCLUDING DEVICE DESCRIPTION.
- DRAFT AND MAINTAIN TECHNICAL FILES FOR ALL MEDICAL DEVICES, ENSURING COMPLIANCE WITH ANNEX-II OF EU MDR 2017/745.
- ENSURE ALL DOCUMENTATION MEETS REGULATORY REQUIREMENTS, INCLUDING SAFETY AND PERFORMANCE STANDARDS.
- UPDATE TECHNICAL FILES AS NECESSARY FOR PRODUCT CHANGES IN PRODUCT DESIGN, MANUFACTURING PROCESSES, OR REGULATORY REQUIREMENTS.
- WORK CLOSELY WITH R&D, MANUFACTURING, QUALITY ASSURANCE, AND OTHER DEPARTMENTS TO GATHER NECESSARY INFORMATION AND ENSURE ACCURACY OF THE TECHNICAL DOCUMENTATION.
- SUPPORT REGULATORY AUDITS AND INSPECTIONS BY PROVIDING NECESSARY DOCUMENTATION AND TECHNICAL FILE EVIDENCE.
- STAY UPDATED WITH CHANGES IN EU MDR AND OTHER RELEVANT REGULATIONS.
- IMPLEMENT NECESSARY CHANGES IN THE TECHNICAL DOCUMENTATION.
- MAINTAIN ACCURATE RECORDS OF ALL VERSIONS OF THE TECHNICAL FILE AND ENSURE DOCUMENT CONTROL.
Sourced from naukri
Skills
About Polymede

Polymede
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IN
About
Poly Medicure Limited (Polymed), a leading Indian Medical device company with a dominant position in medical consumables market with the focus on innovation, safety, and quality. We are one of the fastest growing Medical Devices Company in India. Across the world, we serve in over 100 countries with a wide range of more than 125 different types of products. The product range includes infusion therapy, central venous catheter, blood management system, surgery and wound drainage, anaesthesia, urology, gastroenterology and dialysis. We have 5 domestic (3 Faridabad and one each in Jaipur & Haridwar) and 3 overseas (China,Egypt & Italy) manufacturing facilities. With our strong R&D initiatives, the Company have successfully been granted 215+ product and process patents globally and have also filed for grant of an additional 250+ patents. We are the highest exporter of Consumable Medical Devices from India for the last 6 years. We are also rewarded as “India Medical Device Company of the Year” by DoP, Govt. of India.
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