Senior Quality Design Engineer

4 weeks ago

Galway, Galway, Ireland HRM Search Partners Full time
Senior Quality Design Engineer - Contract (BBBH30500) Galway, Republic of Ireland

This global leader in diagnostics and healthcare technology, renowned for its extensive portfolio of on-market and innovative products, is now on the search for a highly skilled Senior Quality Design Engineer for an initial 12-month contract. As a key player in the medical device industry, this company is expanding its footprint and needs this person to support the establishment of its new legal manufacturing entity in Galway.

The Position:

  • You will support and lead the implementation and maintenance of the QMS to ensure compliance with regulatory standards such as ISO 13485, FDA 21 CFR 820, and more.
  • You will oversee quality operations related to design transfer activities for both entity & IVDR transfers and new product introductions.
  • You will provide expert guidance on quality policies, ensuring adherence to applicable standards and proactively addressing non-compliance issues.
  • You will lead risk management file updates, product and process improvements, and CAPA resolution during design control activities.
  • You will contribute to project goals, ensuring timely and successful design transfer from concept to product launch.
  • You will maintain compliant documentation and develop solutions to overcome quality-related challenges in the design transfer process.

The Person:

  • Bachelor's degree in relevant Science or Engineering-related field.
  • 3+ years of relevant industry experience.
  • Strong knowledge of Quality Management Systems and global medical device regulations (e.g., ISO 13485, FDA, IVDR).
  • Experience in leading projects, ensuring compliance, and managing CAPA investigations.
  • Strong communication, organisational, and problem-solving skills.

The Benefits:

  • Competitive hourly rate.

To discover more about this opportunity, apply now or contact Treasa Prior in HRM Search Partners at +353 87 3983226 for a confidential discussion.

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