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Siora Surgicals logo

Quality Assurance Executive

2 - 5 years

4 - 7 Lacs

Sonipat

Posted:1 month ago| Platform: Naukri logo

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Skills Required

Medical devices Manager Internal Audit ISO 13485 Manager Quality Assurance Test reporting Process validation Customer complaints Executive Quality Assurance Risk management Regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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    Siora Surgicals logo
    Siora Surgicals

    Medical Devices

    New Delhi

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