Quality Assurance Executive - Sonipat, India - Siora Surgicals

Siora Surgicals
Siora Surgicals
Verified Company
Sonipat, India

1 month ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description

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 1497
  • Responsible for customer complaints and inhouse 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 1348
  • 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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