R&D Quality Assurance Specialist

A dynamic start-up specializing in development and manufacturing of innovative medical devices for inhalation of plant substances. They're looking for a QA specialist to support their multidisciplinary and innovative R&D processes and ensure they meet quality standards.
Position Description:
• Ensuring that the company’s quality system procedures and products are in compliance with the regulatory guidelines, regulations, and standards.
• Maintaining design control activities in accordance to ISO13485.
• Ensuring validation processes are performed and documented.
• Provides support for risk analysis processes and technical file maintenance.
• Ensuring compliance of in-house procedures through ongoing, periodic audits or inspections.
• Working closely with engineers and R&D team
• Making quality world accessible to the R&D team
Position Requirements:
• Bachelor’s degree in Engineering or scientific discipline- required.
• 2-3 years of experience in quality assurance, in the Medical Device.
• Experience with R&D QA and with validation processes.
• Experience with quality management systems interactions and audits-Advantage.
• Familiar with quality assurance in a regulated environment.
• Familiar with standards and methodologies (e.g., ISO13485, ISO14971, IEC62304)- Advantage.
• Excellent English writing skills.