Kalite Kontrol Sorumlusu

Firma Bilgisi Gizli

Join Our Growing Team: Quality Management/Assurance Specialist

Are you a passionate pharmacist, chemist, or chemical engineer with a keen eye for detail and a dedication to quality? We are seeking a talented and experienced professional to join our newly formed Quality Management/Assurance department at factory.

About Us:

We are the manufacturer of family-safe anticeptic made with hypochlorous acid. We are committed to developing innovative and effective cleaning solutions that prioritize safety and well-being. We are a global company established one of our plants in Turkey. As we expand our product line, we are building a robust quality system to ensure the highest standards in production and compliance.

About the Role:

In this exciting role, you will play a pivotal role in establishing and maintaining a comprehensive quality management system (QMS) for our HOCl solutions intended for wound, burn, and irrigation applications. You will be responsible for:

·        Developing and implementing quality documentation in accordance with Turkish and international regulations, including Class III CE marking and ISO 13485 certification.

·        Conducting risk assessments and implementing corrective and preventive actions (CAPAs) to ensure product quality and safety.

·        Performing internal audits and collaborating with external regulatory bodies.

·        Staying up-to-date on relevant regulations and industry best practices for medical devices.

·        Preparing and maintaining technical documentation in both English and Turkish.

Qualifications:

·        Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field.

·        Minimum 2 years of experience in the medical device industry or a related field.

·        Strong understanding of quality management principles and practices, including QMS implementation and ISO 13485 requirements.

·        Experience in documentation preparation and regulatory compliance processes.

·        Excellent proficiency in English and Turkish, written and spoken.

·        Strong analytical and problem-solving skills.

·        Ability to work independently and as part of a team.

Benefits:

·        Opportunity to work in a dynamic and growing company with a strong commitment to quality.

·        Be part of a team dedicated to developing innovative and life-saving solutions which has multinational aspects.

·        Work in a fast-paced and collaborative environment.

·        Continuous learning and development opportunities.

If you are a highly motivated and results-oriented professional with a passion for quality, we encourage you to apply!