Site Quality Engineer

Other Responsibilities :

• Continuous Improvement :   Collaborate on short-term and long-term strategies for improving systems and processes, ensuring alignment with business and regulatory requirements.
• Regulatory Monitoring :   Monitor and interpret new and revised regulations and standards, ensuring communication of changes to relevant teams.
• Project Support :   Lead or support projects, initiatives, and other assignments as directed by the RAQA Manager.
• Training Compliance :   Maintain a training matrix for the site and ensure personnel are trained on required procedures before performing site-related activities.

Qualifications

• Bachelor s degree in science or engineering.
• Min. 2 years of experience in Quality Assurance or Quality Control or equivalent. Experience in Regulatory Affairs is preferred.
• Experience in Medical Device domain is preferred.
• Experience working in Multi-national company is preferred.
• Demonstrates profound knowledge and expertise in QMS as per ISO 13485 and Indian Medical Device regulations.
• Experience of handling / leading Regulatory Authority or Notified Body Inspections / Audits.
• Strong learning ability, team player.
• Excellent communication and interpersonal skills, with proficiency in both spoken and written English

Skills Required

Learning Ability, Team Player, Regulatory