Quality Assurance Specialist

Bioeksen Ar Ge Teknolojileri Ltd. Şti.

Bioeksen R&D Technologies was established in 2014 with the R&D Innovation support of KOSGEB. Developing molecular diagnostic products using Reverse Transcription and qPCR/RT-qPCR technologies, the company stands out with 32 R&D projects and 180 products.Its products quickly and reliably detect pathogens in food, water, animal and human samples, while aiming to create less waste with environmental awareness.

As Bioksen, we are looking for a’’Quality Assurance Specialist’’to be a part of our growing organization.The person will be reporting Head of Quality Management & Regulatory Affairs.

Qualifications:

• Bachelor's degree in Biology, Molecular Biology and Genetics, Chemistry or, Bioengineering, Quality Management, Biomedical Engineering, or a related field. Advanced degree preferred.
• Minimum of 3-5 years of experience in Quality Assurance, preferably within the IVD or medical device industry.
• Experience with ISO 13485, ISO 9001, ISO 14971, and regulatory requirements for IVD products.
• Thorough knowledge of quality assurance principles, methods, and practices.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills both in Turkish and English.
• Detail-oriented with a strong focus on accuracy.
• Proficiency in using quality and document management software (i.e. QDMS or similar) and tools.
• Ability to work independently and collaboratively in a team environment.

Key Responsibilities:

• Maintain and continuously improve the Quality Management System (QMS) in accordance with ISO 13485:2016 and other relevant standards e.g. ISO 9001:2015.
• Manage and support document control processes, including the creation, review, approval, distribution, and archiving of quality documents.
• Plan, conduct, and report on internal audits to ensure compliance with the QMS and identify areas for improvement
• Prepare for and participate in external audits and inspections conducted by regulatory bodies, customers, and certification organizations.
• Ensure compliance with all applicable regulations and standards, including ISO 13485, TİTCK, EU IVDR, FDA, ANVISA and other relevant national and international regulations.
• Monitor and ensure the quality of IVD products through inspection, testing, and analysis.
• Develop and deliver quality-related training programs to employees to ensure awareness and understanding of quality standards and procedures.