Kalite Güvence Uzmanı

ASSET MEDİKAL TASARIM SANAYİ VE TİCARET ANONİM ŞİRKETİ

One of Turkey's Prominent Medical Device Manufacturer is Looking for a Quality Assurance Specialist!

Would you consider joining our team as we continue to grow? We are currently seeking a dedicated Quality Assurance Specialist to contribute to our team in the dynamic field of the medical devices industry. 

This role demands a versatile professional who can actively contribute to a comprehensive quality management and regulatory affairs program. The specialist will play a crucial role in maintaining and enhancing product quality, compliance, and continuous improvement initiatives.

Qualifications we are looking for:

- Bachelor's degree in a relevant field (e.g., engineering, biology, chemistry).

- At least 3 years of experience in Quality Management Systems.

- In-depth knowledge of ISO 13485 and MDD 93/42/EEC, preferably MDR 2017/745. 

- Knowledge of global regulatory requirements for medical devices.

- Strong understanding of regulatory submission processes and documentation.

- Preferably having knowledge of MDSAP and FDA 21 CFR Part 820 regulations. 

- Good command of the English language.

- Ability to use MS Office programs effectively.

- Strong analytical skills with attention to detail.

- Excellent communication skills, both written and verbal.

- Ability to collaborate effectively with cross-functional teams.

Job Description:

- Actively participate in the implementation and maintenance of Quality Management Systems, aligning with ISO 13485, MSDAP, and FDA 21 CFR Part 820 regulations.

- Assist in conducting both internal and external audits, contributing to the evaluation of compliance with quality standards and regulatory requirements.

- Support the management of documentation control systems, ensuring accuracy and compliance with regulatory standards.

- Provide assistance in utilizing risk management tools, including Failure Mode and Effects Analysis (FMEA), to contribute to the enhancement of product safety.

- Collaborate with cross-functional teams, including manufacturing, research and development, and regulatory affairs, engaging in collaborative efforts and learning opportunities.

- Monitor supplier quality certificates and participate in supplier evaluations under guidance.

- Assist in conducting root cause analysis and contribute to the implementation of corrective and preventive actions to address quality-related issues.

- Contribute to the oversight of change management and control processes, ensuring the effective implementation of changes in compliance with regulatory standards.

- Participate in cross-functional team efforts to evaluate and document the impact of proposed changes on quality systems and products.

- Support the implementation of robust production floor monitoring activities, including environmental and microbiological monitoring, to ensure adherence to established quality standards and procedures.

- Collaborate with cross-functional teams to contribute to the establishment of validation master plans and ensure alignment with regulatory requirements.

- Contribute to continuous improvement initiatives aimed at enhancing overall product quality and operational efficiency.

- Assist in revalidation activities and contribute to continuous improvement initiatives based on validation findings.

- Participate in monitoring and assessing revisions to international standards and regulations, supporting proactive adaptation and compliance efforts.

- Support the planning, implementation, and improvement of Quality Assurance processes.

- Contribute to monitoring and reporting on the risks, objectives, and needs of Quality Assurance processes.

- Provide assistance in the management and reporting of internal audits.

- Assist in following up on negative incidents related to product quality and contribute to the solution processes.

- Contribute to ensuring that quality records are kept up to date and distributed appropriately.