Job Title: QA Manager
Location: Israel

About Microbot Medical

Microbot Medical is a dynamic, publicly traded, global, medical device startup. The Company develops robotic devices in the endovascular space that provide doctors and surgeons with new technological capabilities to improve a patient’s health, comfort, and quality of life. Our headquarters are in Boston, MA and our R&D and production is in Yokneam, Israel.

Objective

Microbot Medical is seeking a Quality Assurance Manager with extensive experience in the Medical Product development process. The ideal candidate will possess strong technical, data management and interpersonal skills. The quality manager will lead all quality activities and will report to the company’s Sr. Director of QA & RA.

Main Responsibilities

• • Maintenance and management of QA system and document control according to internal and external regulatory requirements
  • Updating/writing company procedures, specifications, work instructions, forms etc.
  • Maintenance of the QA system.
  • Preparing and implementing quality assurance policies and procedures
  • Establish SOP and forms to support
  • Design transfer to production
  • Performing routine inspections and quality tests
  • Ensure that standards and safety regulations are observed
  • Document quality assurance activities and create audit reports
  • Make recommendations for improvement
  • Subcontractors’ approval and control over their performances
  • Supports planning and preparing for inspections and audits
  • Supports leadership in post-audit analysis and corrective action.
  • Support V&V for the company products under development
  • Define QC procedures.
  • Oversee ECO and CAPA processes.

Qualifications & Requirements:

• • B.Sc. degree or higher in a technical discipline, preferably in Biomedical
  • Engineering, Engineering, Biology, Chemistry or equivalent
  • 3+ years of proven experience in establishing, implementing, and managing
  • Quality systems in a medical devices company
  • Experience in ISO13485, CE and FDA – a must
  • Experience in EU MDR – an advantage
  • Working knowledge of tools, methods, and concepts of quality assurance
  • Solid knowledge of relevant regulatory standards (USA and CE)
  • Relevant training and/or certifications as a Quality Assurance Specialist
  • Must possess a positive approach, excellent interpersonal skills, and high personal drive
  • Must be highly motivated and accountable
  • Self-driven with the ability to thrive in a fast-paced, small company environment
  • Good communication skills, both verbal and written
  • Excellent data collection and analysis skills
  • Strong attention to detail
  • Proficient in Word, Excel, and PowerPoint
  • English language proficiency (speaking, writing documents)