Purpose of the Role: To ensure quality management systems are implemented and maintained always Responsibilities:

 To handle all activities related to quality management system, 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 Requirements:

 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