Medical Device Software Quality Assurance Specialist

5 days ago


Dublin, Dublin City, Ireland beBeeSoftware Full time €90,000 - €110,000

As a key member of our team, you will play a vital role in ensuring the quality and compliance of innovative medical devices.

Key Responsibilities:
  • Provide leadership on software quality for new product introductions and sustaining product development teams.
  • Work closely with software developers to optimize processes for efficient iterative generation and maintenance of regulatory deliverables.
  • Support the creation and review of medical device software documentation, including Software Development Plans, Design Specifications, Software Safety Classification, and software issue tracking and resolution.
  • Develop test plans and cases based upon product and component level requirements.
  • Ensure that product development projects comply with applicable regulations and standards, as well as internal procedures.
Qualifications and Skills:
  • Bachelor's degree or higher in a related field.
  • At least 3 years of experience in a regulated work environment, with 2 years in medical devices.
  • Strong technical expertise and communication skills.
  • Verification and validation (V&V) experience required.
  • Expert knowledge of IEC 62304 (Software Development Life Cycle).
  • Good working knowledge of ISO13485 and ISO14971.
  • IEC 62366 knowledge preferred (Usability).
  • Understanding of MDR and CFR requirements.
  • Prior experience with project management tools like Jira/Structure/templated export.


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