Quality Assurance Engineer

3 weeks ago

Delhi, India Madhu Instruments Pvt Ltd Full time

Urgent Job opening for Quality Assurance Executive

Responsibilities

· 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

Qualifications

· Work experience should be minimum 1-2 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

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