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

Deepika Kaur

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:


  • Health insurance
  • Provident Fund

Schedule:

  • Day shift

Supplemental pay types:

  • Yearly bonus

Work Location:
In person

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