Quality Assurance Executive
6 months ago
**Number of Openings**: 01
**Experience**: Minimum 02 to 05 Years
**Salary**: 25K - 30K
**Functional Area**:Quality Assurance
**Industry**: Medical Devices/ Equipment
**Employment Type**: Permanent Job, Full Time
**Job Location**: Plot No. 1792, HSIIDC, Industrial Estate, Rai, District - Sonipat, Haryana.
**Education**: Minimum B.Sc./M.Sc./B. Tech with computer operating Knowledge.
**Key skills**:
- Knowledge of Medical Device Industries, ISO, CE & Indian Medical device Rules 2017(Drug department).
**Responsibility**:
- Deep knowledge of ISO 13485 and ability to make necessary modifications as per requirements.
- Knowledge of EUMDR, Indian MDR and applicable government regulations.
- Responsible for regulatory affairs activities to assist in regulatory submission.
- Responsible for Risk Management as per ISO 14971.
- Responsible for customer complaints and in-house nonconformity.
- To conduct and maintain records of Internal audits and MRM including quality objectives.
- To prepare process validation protocol and perform the validation activity.
- To analyze the process data as per ISO 13485.
- To ensure that test methods are strictly adhered to, test reports are forwarded to the designated authority.
- Implementation of concerned elements of EN ISO 13485:2016, Indian MDR and EU MDR.
**Company Profile**:
One of the leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and has a manufacturing unit at Rai Industrial Area, District Sonipat, Haryana, and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.
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