Quality Assurance Engineer

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