Management Representative

Updated: March 07, 2024 09:10 AM GMT

Full-time Job in Ambernath, Maharashtra

ALAN Electronic Systems - Medical

Thane, Maharashtra, India

Job Description:

Position: Management Representative

Department: Compliance

Location: Ambernath, Maharashtra

Responsibilities:

1. Establish, implement, and maintain all processes necessary for the Quality Management System (QMS) to ensure compliance with regulatory standards.

2. Regularly report to top management on the performance of the Quality Management System and provide insights on areas for improvement.

3. Foster awareness of regulations throughout the organization to ensure alignment with quality objectives.

4. Obtain and maintain mandatory regulatory accreditations, including ISO 13485, ISO 9001, MDR 2017/745 (EU), MDR-2017 (INDIA) etc. and others as applicable as and when required.

5. Independently oversee and manage all aspects of external compliance audits, including coordinating with auditors, preparing necessary documentation, addressing any audit findings, and ensuring compliance with regulatory requirements and standards

6. Document all company policies... More Detail