Quality Assurance Executive - Sonipat, India - Siora Surgicals

Siora Surgicals

Verified Company

Sonipat, India

3 weeks ago

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.