Quality Assurance Executive

About the Company

Peters Surgical

Responsibilities

• To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 13485: 2016.
• Experienced in the preparation or implementation of EU MDR/ MDD documentation and processes.
• Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan etc.
• Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports.
• Experienced in Class III Medical devices.
• Review & modification in all the SOPs & manuals.
• Master list of records-Establishment & updating.
• Master list of documents- Establishment & updating.
• Deviations- Follow-up & records.
• Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies.
• Training- Planning & Imparting.

Qualifications

Science Graduate

Required Skills

1. Work experience should be minimum 2-4 years in

   medical device manufacturing.

2. Understanding of manufacturing methods and quality standards.
3. Strong communication skills, including the ability to explain and teach methodologies.