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Chief Product Safety Specialist

2 weeks ago


Galway, Galway, Ireland beBeeDesign Full time €95,000 - €125,000

Senior Design Assurance Engineer Role

The role of Senior Design Assurance Engineer is to provide technical and compliance expertise in the design and development of medical devices, ensuring adherence to regulatory requirements.

Main Responsibilities:

  • Lead quality-related activities including risk assessments, device testing, internal and external audits, and generation of technical documents.
  • Manage Design History Files (DHF) and continuously improve the Quality Management System (QMS).
  • Collaborate with product development teams to translate user needs into design requirements and generate quality documentation.
  • Execute design verification, validation, and test method validation activities.

Requirements:

  • Bachelor's degree in Engineering, Science, or related technical discipline.
  • Minimum 6 years' experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry.
  • In-depth knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards.
  • Strong problem-solving, decision-making, and analytical skills.
  • Results-driven with the ability to manage multiple priorities in a fast-paced environment.
  • Excellent interpersonal skills with the ability to influence and collaborate effectively across teams.
  • Strong written and verbal communication skills, with fluency in English.
  • Proficiency in MS Office and statistical software.

About This Opportunity

This is a senior-level opportunity to lead quality and compliance activities in medical device design, directly influencing the safety, reliability, and market success of life-changing technologies.