The complete application form along with all the required documents as mentioned below may be forwarded within 20 days of publication of this advertisement.
Post : Lead Auditor / Auditor ; Technical Expert
| Post | Eligibility Criteria |
| Lead Auditor / Auditor | A graduate in Biotechnology or Electrical Engineering or Electronics Engineering or Chemical Engineering or Biomedical Engineering or Mechanical Engineering from a University recognized + 2 years of experience in manufacturing or research or quality assurance or testing in medical device field. or A graduate in Science or Pharmacy+ minimum of 3 years of experience in the manufacturing or research or quality assurance or testing in medical device field. or Diploma in Engineering or Pharmacy from a Board or Institute recognized by the Central Government or the State Government + 4 years of experience in the manufacturing or research or quality assurance or testing in medical device field. or -For Lead Auditor a minimum of 3 audits as team leader and at least 50 man-days of experience in auditing ISO 13485. -For Auditor a minimum of 4 audits with a total of 20 man-days of experience in auditing ISO 13485. -Valid 5 Days Lead Auditor training certification for ISO 13485 from a recognized body. |
| Technical Expert | A graduate in Biotechnology or Electrical Engineering or Electronics Engineering or Chemical Engineering or Biomedical Engineering or Mechanical Engineering or in any equivalent field plus minimum of 3 years of experience in the design and development or manufacturing or research or testing or quality in medical device field. or M.Pharm / M.Sc or in any equivalent field plus minimum of 2 years of experience in the design and development or manufacturing or research or testing or quality in medical device field. Required Knowledge and Skills • Knowledge and skills of standards IS013485, ISO 9001, ISO 14971 and ISO/IEC 17021-1. |
Application Process
- To apply for empanelment, please fill the application form and enclose required documents as requested in application form.
- Updated Curriculum Vitae (CV) highlighting your relevant experience and qualifications.
- Audit log details of your previous audit assignments, including the scope and duration.
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