Quality Assurance Executive (medical devices)

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

Full time