KIHT Certification Services (KCS) is a division under the Kalam Institute of Health Technology (KIHT) dedicated to certification activities for Medical Device Quality Management System (MDQMS) as per ISO 13485:2016. Supported by the Department of Biotechnology under the Ministry of Science and Technology, KIHT aims to uphold quality standards in the medical device sector. The institution, established in July 2017, is located in Visakhapatnam.

Role Description

This is a full-time on-site role for a Lead Auditor at KIHT Certification Services. The Lead Auditor will be responsible for conducting audits related to the Medical Device Quality Management System (MDQMS) as per ISO 13485:2016 standards. The role will involve assessing compliance, identifying areas for improvement, and ensuring adherence to accreditation requirements.

Qualifications

Strong knowledge of ISO 13485:2016 standards and ISO/IEC 17021-1:2015 requirements
Experience in auditing Medical Device Quality Management Systems
Excellent analytical and problem-solving skills
Effective communication and interpersonal skills
Attention to detail and ability to work independently
Certification as an ISO Lead Auditor is preferred
Bachelor's degree in a relevant field, such as Healthcare Quality Management or Auditing

More Jobs at KIHT Certification Services

Lead Auditor

Visakhapatnam, Andhra Pradesh, India

Experience: Not specified

Salary: Not disclosed

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Lead Auditor