QA Executive

2 weeks ago

Bengaluru, India Janacare Full time

**Company **: Jana Med Tech Pvt Ltd

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

*
- Knowledge on ISO 9001, EN ISO 13485:2016 & ISO 14971

Regards
Minakshi Paul

+91-XXXXXXXXXX

**Job Types**: Full-time, Volunteer

**Salary**: ₹450,000.00 - ₹550,000.00 per year

Schedule:

- Day shift

Ability to commute/relocate:

- Bangalore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 2 years (preferred)

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