Quality Assurance Specialist İş İlanları

GENEL NİTELİKLER

We are looking for Quality Assurance Assistant Specialist/Senior Specialist having the following qualifications to be employed in our company located in Çatalca.

Bachelor's degree in Chemistry/Pharmacy/Microbiology/Medicine or related scientific discipline

At least 2 years experience in the medical device or related industry, ideally with a mix of Manufacturing/ QA operations, Quality control, Regulatory Affairs experiences

Preferably understanding of medical device product development, qualification, manufacturing, packaging, validation,testing, release and distribution processes

Up-to-date knowledge with ISO 13485, MDD (93/42 EEC)

Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners

Full compentency in local languages and working knowledge of English

Male candidates should have completed their military service

Good command of MS Office programmes

JOB DESCRIPTION

Follow the currency and delivery of quality documents and records

Leading and monitoring the quality processes such as Auditing, nonconformities, CAPAs, documentation management etc.

Responsible to Complaint Handling and communication to Vigilance Autorities

Participate Risk Assessment activities.

Prepare quality reports with quality processes.

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