Quality Assurance Engineer

Meditera Tıbbi Malzeme Sanayi ve Ticaret A. Ş.

Qualifications

• 1-3 years related experience in the medical industry,
• Strong knowledge of ISO 13485:2016, MDD 93/42/EEC and 2017/745 MDR requirements,
• Excellent communication skills, both written and verbal,
• Problem solving skills,
• Able to work well within a team,
• Highly organized with strong attention to detail,
• Self motivated,
• Ability to prioritize the workload and effective time management,
• Able to review, trend, analyze and report data using databases and/or Excel,
• Good command of English,
• Male candidates must have completed their military service,
• Preferably residing or able to live in Tire,

Job Descrıptıon

• Performing the preparation and coordination of technical file for CE and FDA,
• Performing the preparation and coordination of documents for registration,
• Supporting the review, update and implementation of procedures to ensure compliance to regulations and standards,
• Performing the preparation and coordination of internal and external audits,
• Providing Quality support to Operation daily activities,
• Collaborating with engineering and manufacturing functions to ensure quality standards are in place,
• Assisting with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards.