Quality Assurance Executive - Okhla, Delhi, Delhi, India - Madhu Instruments

Madhu Instruments

Verified Company

Okhla, Delhi, Delhi, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including

Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc.
Fulfilment of regulatory requirements related to EC directive, various Govt. tenders & registration of overseas.
Follow up of local regulatory & drugs requirements.
Validation

- machines, processes, clean rooms, material & sterilization.

Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of nonclosure reports.
Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall.

MRM

Organizing & follow up actions from previous meetings.
Review & modification in all the SOPs & manuals.
Master list of records
Establishment & updating.
Master list of documents
Establishment & updating.
Deviations
Follow up & records
Corrective & preventive actions
Corrections, implementations & maintenance.
Calibration of equipment and machines of production & quality control.
Handling out the predispatch inspections of shipments by the outside agencies and certification bodies.
Training
Planning & Imparting

Requirements:

Work experience should be minimum 34 years in medical devices manufacturing.
Excellent computer skills
Goal Oriented
Strong communication skills, including the ability to explain and teach methodologies
Understanding of manufacturing methods and quality standards
A confident and determined approach
Excellent organizational & time management skills
Team player

Pay:
₹35, ₹45,000.00 per month

Benefits: