Product Safety Expert

2 weeks ago

Galway, Galway, Ireland beBeeAssurance Full time €60,000 - €80,000
Job Title:

Design Assurance Engineer



Job Description:

The role involves managing design changes, ensuring continued compliance with regulatory requirements, and supporting complaint investigations to uphold the safety and effectiveness of medical devices. This includes maintaining and updating the risk management file for post-market products, generating Design Verification plans, protocols & reports, and executing DV testing to support product / material design changes and collection of shelf-life data.



Requirements:
  1. 2-3 years experience in a related field (can be from MNC or start up)
  2. Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents
  3. Experience with design control and risk management throughout the product lifecycle, post-market surveillance, complaint investigations, and CAPA systems


Benefits:
  • Excellent salary
  • Pension
  • Healthcare
  • Yearly bonus
  • Share options


Day to Day Responsibilities:
  1. Support sustaining commercial projects from a Design Assurance perspective
  2. Lead and execute product / material design changes for commercially released products in accordance with regulatory and internal quality system requirements
  3. Maintain and update the risk management file for post-market products
  4. Generation of Design Verification plans, protocols & reports and execution of DV testing to support product / material design changes and collection of shelf-life data
  5. Ensure continued design control compliance, including design history file (DHF) maintenance, verification/validation planning, and traceability
  6. Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA)

Would you like to discuss further details about this role? Let me know if you are interested in having a call.

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