Prognosys Medical Systems Pvt Ltd
Website:
prognosysmedical.com
Job details:
Responsibilities
-Responsible to plan, review, monitor and conclude QA Radiation test and image quality test related to product and authorized to act as signatory for related records.
-Responsible to support the department in fulfilling the objectives.
-Responsible to plan, monitor, improve and educate the departments for Radiation Safety Guidelines as per AERB applicable in defined testing areas in the organization as per the documented procedure and authorized to act as signatory for related records.
-Responsible to execute, monitor & co-ordinate for TLD badge and Dosage monitoring process from certified Lab and authorized to act as signatory for related records.
-Responsible to execute, monitor & co-ordinate for activities related to product type approval, data upload on eLORA web portal and authorized to act as signatory for related records.
-Responsible to report and coordinate Radiation control related activities with department head and RSO.
-Responsible to review 3rd party QA radiation test reports related to product.
-Responsible to support for customer complaints and CAPAs process for products and authorized to act as
signatory for related records.
-Responsible to support for application installation & demonstration for products and authorized to act as
signatory for related records.
-Responsible to work effectively with various work groups & ensure conformance to regulatory requirements, internal QMS processes and company policies.
-Responsible to support in QMS improvements as per need of the system & departments.
-Authorize to support the management for organizing routine QMS activities such as MRM, Internal Audits,
trainings, PMS, etc. and act as signatory for related records.
-Authorize to act as signatory for approval of records related to AERB and TLD monitoring, Radiation dosage etc.
-Authorize to act as signatory for representing Quality in any process, training or meeting in the organization.
Qualifications
-B.E. Diploma in Electrical/Electronics/Biomedical
-Minimum 2 years of experience in (RSO) Radiation Safety Officer domain in Medical Device Organization / Healthcare Institute
-RSO certification is mandatory (AERB)
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