Establishment and implementation of QMS in accordance with ISO 13485- 2016

Management of design control and change controls in the company

Management of non- conformities, CAPAs and internal audits

Suppliers qualification and evaluation

Writing quality procedures

Management of trainings and adequate competency within the company

Traceability through the product realization

Management of documentation control, DHF, DMR and DHRs

Management and handling of the clean room activities; monitoring, ISO 7 validation and control activities

SKILLS

Bachelor’s Degree in science or mechanical / medical engineering

At least 3 years’ experience in leading QMS activities in medical device

Fluent English

Good writing skills