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14 Madhu Instruments Jobs

Quality Assurance Executive

5-7 years

New Delhi

1 vacancy

Quality Assurance Executive

Madhu Instruments

posted 27d ago

Job Role Insights

Fixed timing

Job 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 non-closure 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 pre-dispatch inspections of shipments by the outside agencies and certification bodies.
Training- Planning & Imparting

Employment Type: Full Time, Permanent

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What people at Madhu Instruments are saying

What Madhu Instruments employees are saying about work life

based on 14 employees
67%
89%
62%
100%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Madhu Instruments Benefits

Soft Skill Training
Work From Home
Job Training
Cafeteria
Team Outings
Health Insurance +6 more
View more benefits

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