Job Title: QA Engineer
Reports To: CTO
Position Scope: Full Time
Location: Yokneam, Israel

Objective:

QA Engineer for a startup company in the field of medical devices (medical robotics).

The Quality Affairs Engineer will have extensive experience in Medical Product development process – Electromechanical Devices. The ideal candidate will possess strong technical, data management and interpersonal skills. The quality engineer will lead all quality activities. Must be highly motivated, self-directed, and possess the ability to thrive in a fast-paced startup environment

Main Responsibilities:

  • Quality Assurance
  • Establish and maintain QMS
  • Write Standard Operating Procedures (SOPs) to ensure compliance with standards
  • Implementation of the SOPs and managing the company’s daily QA activities
  • Participate in the definition of V&V testing protocols
  • Perform V&V on the company’s products under development
  • Handle S/W and other validations
  • Contractor/Vendor management
  • Define QC procedures
  • Compilation of DHF and Technical Files
  • Responsibility for Regulatory-related activities including:
    -Readiness for CE audits
    -Interaction with testing and accreditation authorities
    -Risk management file 

Qualifications & Requirements: 

  • BSc. degree or higher in a technical discipline, preferably in Biomedical engineering, Engineering, biology, chemistry / equivalent
  • 3+ years’ proven experience in establishing, implementing and managing Quality systems in a medical devices company
  • Experience in ISO13485, CE and FDA – a must
  • Experience in Regulatory Affairs – an advantage
  • Ability to create documents and presentations in collaboration with R&D Team through Word, Excel and PowerPoint
  • Oral and written English language proficiency
  • Excellent analytical and problem solving skills
  • Must be positive and highly motivated, with excellent interpersonal relations as well as the ability to hold accountability
  • Must be a team player with the ability to work independently
Pre-Application Form