QA Specialist

Syqe Medical is a dynamic start-up specializing in the design, development, and manufacturing of innovative medical devices for inhalation of plant substances. We’re looking for a QA specialist to join our team and support the development and implementation of the company’s QA effort.

The position located in Tiberias.

Responsibilities:

• Lead investigations into quality incidents, deviations, and non-conformances, implementing corrective and preventive actions (CAPAs).
• Provide guidance and training to team members on quality procedures, protocols, and GMP requirements.
• Ensure that the Company’s quality system procedures and products are in compliance with regulatory guidelines, regulations, and external standards.
• Perform controls and verify quality for all sub-contractors, suppliers, production processes and R&D
• Ensure validation processes are performed and documented
• Ensure compliance with in-house procedures through ongoing, periodic audits or inspections
• Review and approval of change controls, ensuring thorough evaluation and documentation of all changes impacting product quality according to the applicable risk management procedure.
• Review and approval of validation protocols and reports to ensure compliance with regulatory requirements and industry best practices.
• Conducting annual product reviews, communicating findings and recommendations to the management team.
• Conducting annual critical systems reviews and trend analysis.
  
  

• A Bachelor’s degree in a technical or scientific discipline is required (preferred life science).
• 3-5 years of experience in quality assurance, in the pharmaceutical/Cannabis industry
• Experience with quality management systems interactions and audits
• Understanding of quality assurance in a regulated environment
• Experience with manufacturing and validation processes
• Familiar with quality management standards and methodologies (e.g., ISO, GMP, Eudralex Vol. 4 standards, Continuous Improvement)
• Fluent English & Hebrew, and writing proficiency.