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System QA tester

QA | Haifa

Rolls & responsibilities

  • Analyze and investigate product complaints from the field
  • Open and follow up on life-cycle issues
  • Review design specification documents for accuracy, completeness, and compliance.
  • Create test protocols and test reports following execution.
  • Involved in the technical design reviews.
  • Involved in the risk analysis of the product design.
  • Reporting to the Design QA Team Leader.

Required

  • Engineering Bachelor’s Degree, Bio-Medical is preferred.
  • Practical experience of 5-10 years of Design Quality Assurance in medical devices
  • Proven skills to perform tasks accurately.
  • Read, understand, and interpret documents such as design specifications, safety rules, and technical procedure manuals.
  • English proficiency at a very high level.
  • Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts, and drawing valid conclusions.

Advantages

  • Working knowledge of relevant regulations and standards (e.g. ISO 13485, 21 CFR 820, MDR, ISO 14971
  • Programming experience (any language)
  • Data analysis experience

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