Ajay J
Manager Qara @Kooper Medical Technology Private Limited
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WORK HISTORY
Manager Qara @Kooper Medical Technology Private Limited
IN
Ø Creation and maintenance of all Quality Management System (QMS) documents in accordance with ISO 13485 standardsØ Proficient in preparing regulatory documents, particularly experienced in handling IMDR -2017 documentation.Ø Oversee and conduct all Quality Assurance (QA) activities, including audits, approvals, and process reviews.Ø Collaborate with cross-functional teams to integrate quality and regulatory requirements.Ø Drive continuous improvement initiatives within the QA RA department, identifying areas for enhancement and implementing corrective actions.Ø Stay up-to date of regulatory intelligence and industry trends, providing insights to senior management for informed decision-making.Ø Analyze customer feedback and complaints, utilizing this information to identify trends and opportunities for improvement.
EDUCATION
Government polytechniccollege palakkad
Diploma
Bharathiar University
Bachelor of Commerce - BCom
Parli HigerSecondary school
SSLC
Jain (Deemed-to-be University)
MBA
Pandit Motilal Government HigherSecondary School Palakkad
HigherSecondary Education
ABOUT AJAY J
Quality-focused MBA Graduate specializing in Systems and Operations Management. I hold a…
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