Number of Openings : 01 Experience : Minimum 08 Years Salary : 40K -45K Functional Area : Quality Assurance Industry : Medical Devices/ Equipment Employment Type : Permanent Job, Full Time Job Location : Plot No. 1792, HSIIDC, Industrial Estate, Rai, District – Sonipat, Haryana. Education : UG: B Tech in Mechanical, BE – Bio Medical, B. Pharma, B. Tech Medical Science Key skills: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017. Responsibility: Create and maintain company quality documentation, such as manuals, procedures, etc. Continuously improve QA processes and procedures. Preparation of QA reports. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012. Desired Candidate Profile: Implementation and improvement in Quality Management System as per ISO 13485:2016. Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP. Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval. Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance. Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch. Giving line clearance before starting the New Batch. Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas. Company Profile: One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station. Note: Kindly mail your resume at [email protected]. Our HR team will call you for the interview if your resume is shortlisted.