Quality Specialist

Job Description:

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

In our Quality and Regulatory Affairs organization in Istanbul, the Quality Specialist will lead key quality systems, strengthen compliance frameworks, and drive continuous improvement across our organization. This role will play a critical part in enhancing quality culture, managing post market activities, and collaborating with global teams to ensure operational excellence and regulatory compliance.

This position is located in Istanbul.

What will your responsibilities be?

* Oversee Quality Assurance tools, processes, and continuous improvement initiatives

* Collaborate with local & global teams to strengthen quality systems of the subsidiary

* Develop and deliver training to enhance quality competencies across teams

* Manage Post-Market Quality topics: Vigilance, Field Actions, audits, risk analysis

* Support internal and external audits, ensuring compliance with regulatory standards

* Execute supplier and distributor quality audits and contribute to improvement strategies

* Solve moderately complex quality issues and drive enhancements to existing processes

Who are you?

* Minimum 3 years of expertise in quality management systems and regulatory compliance (ideally in in-vitro diagnostics or medical devices)

* Hands-on experience in audits, Post Market Quality, supplier and distributor quality management (especially ISO9001)

* The ability to work independently while influencing and supporting cross functional teams

* Strong analytical capabilities with a solution-oriented mindset

* A passion for continuous improvement and high-quality standards

* Excellent communication skills, including strong international communication competencies

* Experience supporting internal and external audits

* Strong sense of ownership and accountability

* Having a Regulatory Affairs and/or Compliance background is a strong asset, including prior experience in product registration, licensing, and compliance processes

* Turkish and English proficiency

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Job ID: 56444