job opening for the post of Quality Assurance Executive-sonipat haryana @ balaji placement

location-sonipat
Create and maintain company quality documentation, such as manuals, procedures, etc.
Continuously improve QA processes and procedures.
Preparation of QA reports.
Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012
Experience: Minimum 02 Years
Salary: 20K -25K
Industry: Medical Devices/ Equipment
Functional Area: Quality Assurance
Key skills:
Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
Desired Candidate Profile
Implementation and improvement in Quality Management System as per ISO 13485:2016.
Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.
Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.
Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.
Giving line clearance before starting the New Batch.
Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas.
Experience of CE, ISO 13485:2016 and GMP Inspections.
Experience of Risk Management as per ISO 14971
Experience of Design & development file as per ISO 13485:2016
Knowledge of Post Market Surveillance and Post Market Clinical Follow Up, Product recall-Handling and handling market complaints as per SOP and maintaining its records.
Education
UG: B Tech in Mechanical, BE - Bio Medical, B. Pharma, B. Tech Medical Science

if interested pls mail your [Confidential Information]

balaji placement service

gita bhawan chowk,

sachdeva button store sonipat

9729188***