QA Engineer

Randstad Türkiye

A minimum of a Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science or related disciplines
2-3 years QA Experience in medical device/pharma industry, including implementing ISO 13485/9001 compliant QMS
Knowledge of ISO 13485
Experience in conducting audits
Experience in CAPA management

İŞ TANIMI

Support all QA activities for commercial organisation
Manage day-to-day running of the QMS including document control and record management and develop the QMS in accordance with ISO 13485 requirements
Manage customer complaints
Coordinate local implementation of Quality Holds and Recalls
Work with cross functional teams to ensure compliance and improvements in processes, particularly with supply chain and distribution channels
Lead the QA activities to improve warehouse operations and ensure compliance to ISO 13485 requirements and manage quality aspects of warehouse processes e.g. control of nonconforming product
Manage the internal audit programme - plan internal audit agenda and conduct relevant internal audits
CAPA management
Support external audits as needed
Create awareness on QMS requirements within the organisation and provide training as necessary