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Madhu Instruments Pvt ltd
Madhu Instruments Pvt ltd
12 Followers
12 Followers
Delhi

Urgently required experienced Quality Assurance Executive for Okhla, Delhi Location


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 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’s and machines of production & quality control.
Handling out the pre-dispatch inspections of shipments by the outside agencies
Key Skills
Experience in medical devices
Required Experience and Qualifications
Education- B.Sc. degree, masters may be preferred.
Experience 3-4 years as a Quality Assurance executive in medical devices/pharmaceuticals


Job Type

Full Time


Course


Skills


Work Experience (In Year)

3 - 4


Address

Okhla phase 2, Delhi

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