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Location
Type
Status
Open
Bengaluru, Karnataka

Full Job Description

Company : Jana Med Tech Pvt Ltd

Website: www.janacare.com

Position title: We are looking for a QA - Executive (ISO 13485) for a Medical Devices (IVD) Manufacturing Industry.

Job Description

Support the creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations.

Assist in planning and execution of the audit activities necessary for monitoring the Quality Management system and participate as a team member in all internal/external audits.

Assist QA Lead in conducting management review meetings on defined intervals and record meeting minutes.

Review and approve completed batch records and equipment logs for completeness and also ensure on time calibration activities and preventive maintenance is completed. Escalate issues for appropriate handling.

Track and support training activities to ensure on time training completion for all employees, this includes new employee training, skill training and change implementation training for new/revised documents.

Support as required to track and report out the Quality metrics (CAPA, NCR’s, Supplier monitoring etc) on a periodic basis for the site by working closely with various functional groups.

Responsible for batch release of the products prior to shipment to customers.

Assist in overall improvement of Production facility as per QMS.

Mandatory:

QA experience in the manufacturing unit, preferably in the manufacturing of Medical devices.

Knowledge on QMS, GMP & GDP

Good communication skill.

Root cause identifying skills & Problem solving skills.

Knowledge of MS Office.
Bengaluru, Karnataka Full Job Description Company : Jana Med Tech Pvt Ltd Website: www.janacare.com Position title: We are looking for a QA - Executive (ISO 13485) for a Medical Devices (IVD) Manufacturing Industry. Job Description Support the creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations. Assist in planning and execution of the audit activities necessary for monitoring the Quality Management system and participate as a team member in all internal/external audits. Assist QA Lead in conducting management review meetings on defined intervals and record meeting minutes. Review and approve completed batch records and equipment logs for completeness and also ensure on time calibration activities and preventive maintenance is completed. Escalate issues for appropriate handling. Track and support training activities to ensure on time training completion for all employees, this includes new employee training, skill training and change implementation training for new/revised documents. Support as required to track and report out the Quality metrics (CAPA, NCR’s, Supplier monitoring etc) on a periodic basis for the site by working closely with various functional groups. Responsible for batch release of the products prior to shipment to customers. Assist in overall improvement of Production facility as per QMS. Mandatory: QA experience in the manufacturing unit, preferably in the manufacturing of Medical devices. Knowledge on QMS, GMP & GDP Good communication skill. Root cause identifying skills & Problem solving skills. Knowledge of MS Office.
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