Design Assurance Engineer – Galway

Design Assurance Engineer required by a market leading Medical Device multinational based in Galway.

Key Responsibilities:

  • Participates in new product development and leads.
  • Executes the project design plans, protocols.
  • Partner with R&D and Process Engineers to ensure that the transition of products.
  • Liase with R&D, Operations & Customers in the development, customization and control of product labelling.
  • Defines and implements quality standards and specifications and helps to ensure that regulatory requirements are met.
  • Develops and executes required validations in line with regulatory standards.
  • Promotes compliance and excellence within the company.
  • Conducts audits, including closing out audit findings.
  • Creates and maintains company quality documentation.
  • Conducts root cause analysis and implements corrective action.

 

Requirements: 

  • BSc. in Engineering or Quality.
  • 3+ years as a Design Assurance Engineer within a Medical Device or regulated environment.
  • Strong working knowledge of the product development process within the medical device industry.
  • Detailed knowledge of the regulatory environment.
  • Ability to support and lead DA activities on multiple projects simultaneously.
  • Strong technical writing and verbal communication skills.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Must be authorised to work in Ireland.

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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