Design Quality Assurance Professional

2 weeks ago

Galway, Galway, Ireland beBeeDesignQuality Full time €80,000 - €110,000
Design Quality Assurance Engineer Job Description

Job Purpose:

We are seeking a skilled Design Quality Assurance Engineer to ensure design changes comply with regulations and procedures. The successful candidate will be responsible for understanding requirements and procedures that govern medical device Design Control.

Key Responsibilities:

  • Effective understanding of requirements and procedures that govern medical device Design Control.
  • Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
  • Develop and maintain the Product Development Process (PDP) Design History File, supporting deliverables including design inputs, design outputs, design verification, design validation, useability risk management and design reviews.
  • Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
  • Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations team environments to provide technical and quality systems input.
  • Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
  • Ownership of design change projects including scoping, assessment and implementation.
  • Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
  • Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI's and EU/FDA/Global guidelines.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Requirements:

The ideal candidate will have experience working with design assurance requirements and regulations. Strong analytical and problem-solving skills are required to make decisions based on test data. Excellent communication skills are necessary to interface with various teams.

Benefits:

This role offers the opportunity to work in a dynamic environment where you can apply your knowledge and skills to drive quality excellence. You will have the chance to collaborate with cross-functional teams and contribute to the development of innovative products.

Other Information:

The selected candidate will undergo thorough screening and background checks before joining our organization.

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