A Naukri Group company
LoginHire Local Staff
A Naukri Group companyLoginHire Local Staff
25,000 - 30,000 /month
Growth Hub Consultants
Okhla Phase 1, Delhi
2 - 3 years Experience in Manufacturing
Full Time
Key Responsibilities:
· ISO 13485 Implementation & Maintenance:
o Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 standards.
o Review and update QMS documentation to reflect any changes in regulations or procedures.
o Lead internal audits and ensure timely completion of corrective and preventive actions (CAPA).
· Regulatory Compliance:
o Monitor changes in ISO 13485 and other relevant medical device regulations.
o Collaborate with regulatory bodies during inspections and audits, ensuring full compliance.
· Training & Education:
o Provide training to staff on ISO 13485 requirements and best practices.
o Conduct regular audits and assessments to ensure compliance.
o Lead continuous improvement initiatives related to quality assurance processes.
· Documentation & Reporting:
o Maintain and control documentation related to the QMS (e.g., SOPs, work instructions, CAPA reports).
o Generate regular quality reports and metrics for senior management.
o Handle nonconformance reports (NCRs) and investigate any issues to prevent recurrence.
