Quality Assurance Regulatory Affairs Manager

Company Description

Elesonic 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 Description

This 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.

Qualifications

• Implementing and acheiving Quality Control, Quality Assurance, and Quality Management skills Experience in Quality Control and Quality Assurance processes
• Proficiency in Quality Management systems and practices
• Knowledge of Medical Device Regulations (i.e - AERB / BIS / CDSCO / ISO 13485 European / CE European )
• Strong analytical and problem-solving skills
• Excellent attention to detail and organizational abilities
• Ability to work effectively in a team and independently
• Bachelor's degree in a related field (e.g., Life Sciences, Engineering, or Quality Management
• Must Have Physics one of the Subject in Bachelor's Degree
• Radiological Safety Officer ( RSO ) Exam from AERB passed is preffered and if not passed then have the ability to pass
• Prior experience in the medical equipment industry is a plus

Skills Required

Iso 13485, Quality Management, Quality Assurance, Quality Control