About the CompanyPeters Surgical is a French multinational company, a global leader in medical device sector having presence since 1926 and having turnover of 82M Euro. The company is present in 6 countries and serves more than 90 countries. It provides solutions for two therapeutic areas (CV & Surgical Specialties) (Sutures, clamps, clips, meshes, surgical glue, laparoscopic instruments) improving the quality of patient care.ResponsibilitiesTo handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 13485: 2016.QMS Document preparation.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.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.Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies.Training- Planning & Imparting.QualificationsScience GraduateRequired SkillsWork experience should be minimum 2-4 years in medical device manufacturing.Understanding of manufacturing methods and quality standards.Excellent computers skillStrong communication skills, including the ability to explain and teach methodologies.
Job Title
Quality Assurance Executive