Quality Assurance Regulatory Affairs Manager

Company DescriptionElesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray and C-arm machines. By 2019, Elesonic expanded its operations to African Union through offices at Nigeria and Uganda. Same Year in 2019 Elesonic established a presence in Canada for Trans atlantic operation including Carribean Islands. Our pledge is to deliver quality and exceptional service in the industry. Join us in making the world a healthier place!Role DescriptionThis is a full-time, on-site role for a Quality Cum Regulatory Assurance Executive located in Kolkata. The role involves overseeing and implementing quality control and assurance processes, conducting quality audits, and managing quality systems. The executive will ensure compliance with regulatory standards and work closely with various departments ( I.E - AERB / BIS / CDSCO / EUROPEAN AGENCY FOR ISO AND CE ) to maintain high-quality manufacturing standards for medical equipment.QualificationsImplementing and acheiving Quality Control, Quality Assurance, and Quality Management skills Experience in Quality Control and Quality Assurance processesProficiency in Quality Management systems and practicesKnowledge of Medical Device Regulations (i.e - AERB / BIS / CDSCO / ISO 13485 European / CE European )Strong analytical and problem-solving skillsExcellent attention to detail and organizational abilitiesAbility to work effectively in a team and independentlyBachelor's degree in a related field (e.g., Life Sciences, Engineering, or Quality ManagementMust Have Physics one of the Subject in Bachelor’s DegreeRadiological Safety Officer ( RSO ) Exam from AERB passed is preffered and if not passed then have the ability to passPrior experience in the medical equipment industry is a plus