Quality Assurance Executive Job in Siora Surgical Pvt Ltd

Quality Assurance Executive

Siora Surgical Pvt Ltd 4+ weeks ago

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Job Summary

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.

Qualification :
B.Sc./M.Sc./B. Tech

Experience Required :

2 to 5 Years

Vacancy :

1 Hire

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