Quality Control Engineer

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.

• It is a Full Time తయారీ job for candidates with 2 - 3 years of experience.