Quality Assurance Executive Job at Sonipat, Haryana, India Full Time

URGENT HIRING FOR – QUALITY ASSURANCE EXECUTIVE

Preferred immediate joiner

email – [email protected]

contact no. – 7415074707

Location – Sonipat, Haryana

Experience – 3 – 7 years

CTC – UPTO 4.8 LPA

Preferred Industry – Medical Devices/ Equipment

Key Responsibilities:-

· 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

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

Interested candidate can apply along with there resume in the mention email id or contact in whats app

Mail – [email protected]

Mob – 7415074707