QUALITY MANAGER & CONSULTANT
As Quality Manager and Consultant at Archimedic, Gulnar manages Archimedic's Quality Management System and provides Quality support to clients.
Gulnar has worked in the medical device field for over 20 years. She started her career in research development at large global medical device organizations working on range of products including imaging systems, colonoscopes and neuro-stimulators.
In 2010 her career pivoted to the fields of Quality and Regulatory, where she held leadership positions at a number of start-up companies. She has written, implemented and maintained full FDA and ISO 13485 compliant quality systems for multiple organizations from ground up. Working at smaller companies, Gulnar was able to gain practical hands-on experience in all areas of quality regulation including production and process controls, design controls, CAPA, supplier evaluations and complaint handling. She also has held direct responsibility for regulatory functions such as site registrations, premarket submissions and adverse event reporting.
Recently her primary focus has been new product development including design controls, risk management, clinical trial compliance and pre-market submissions. Gulnar has supported these activities for a diverse portfolio of products including contact lenses, adhesives and wearable electronics, infusion pumps, and medical device software applications.
At Archimedic, Gulnar leads the Quality department, where she maintains all aspects of the firm's quality management system and ISO 13485 certification. In this role, Gulnar collaborates closely with the product development team to train, audit, and instill a mindset of continuous improvement. Additionally, Gulnar is an active contributor providing quality and regulatory consulting services to our clients, including SOP development and DHF document creation.
Gulnar holds a Bachelor of Science in Mechanical Engineering from Ohio State University.