Log In
Sign Up
Private Jobs / Private Sector
Madhu Instruments Pvt. Ltd Hiring for Quality Control officer at Delhi, Delhi Full Time
We are a company based in New Delhi, INDIA and have built a strong reputation as a reliable supplier of high quality ophthalmic products in the domestic and international market.
Our product range includes specialty products for Cataract & Phaco, Keratoplasty, Vitreo-retina surgery, Ophthalmic Diagnostic Strips, Diagnostic & Surgical Lenses, Fluid Management Devices and Teaching & Training Devices among many others.
We aim at offering innovative products to the ophthalmic community and improving upon the existing products to the utmost satisfaction of our esteemed customers.
Job Description:
ob Summary
Urgently required experienced Quality Assurance Executive for Okhla, Delhi Location(Only from medical device Manufacturing company)
Responsibilities and Duties
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 equipments and machines of production & quality control.
Handling out the pre-dispatch inspections of shipments by the outside agencies
*
Interested candidates can send their updated resume (hr at madhuinstruments.com) or can call 8130384348
Functional Area:
Quality Control
Candidate Requirement
ob Summary
Urgently required experienced Quality Assurance Executive for Okhla, Delhi Location(Only from medical device Manufacturing company)
Responsibilities and Duties
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 equipments and machines of production & quality control.
Handling out the pre-dispatch inspections of shipments by the outside agencies
*
Interested candidates can send their updated resume (hr at madhuinstruments.com) or can call 8130384348.
Experience:
1 – 2 years