Quality Assurance Engineer
5 days ago
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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