Health Software Regulatory QA Engineer

Santa Clara Valley (Cupertino), California, United States
Software and Services

Summary

Posted: Jan 3, 2019
Role Number: 200009872
The Health Software QA team is seeking a Regulatory QA Engineer to help us ensure that our Health related applications are high quality, user-focused, and in accordance with FDA and ISO regulations. We understand the most up to date system configurations, develop and update test procedures and documentation, execute structured test passes and reports, and work multi-functionally with other involved quality teams.

Key Qualifications

  • Ability to investigate and debug difficult problems
  • Creative thinker and strong problem solver with meticulous attention to detail
  • An enthusiasm for user-focused design & high-quality technology
  • At ease and adaptable in a dynamic and informal environment
  • Extensive experience in IEC 62304
  • Has experience with Software risk assessments
  • Excellent written and verbal communication skills to facilitate close interaction with development teams, management, and other organizations within Apple
  • Highly organized, creative, motivated, and passionate about achieving results

Description

In this position you will need to be self-motivated with strong technical and social skills. You will handle responsibilities such as the functional testing of applications including Health, Heart, and Workout. Your responsibilities will include design and implementation of test plans and test cases, risk analysis, & integration testing across the system.

Education & Experience

BS in Computer Science or equivalent on-the-job experience in software medical device quality industry

Additional Requirements

  • Thorough knowledge of ISO and FDA regulations
  • Software literacy with Apple's watchOS, iOS, and macOS