Quality Assurance Manager

5 days ago

Galway, Galway, Ireland beBeeDesign Full time €75,000 - €102,000
Senior Design Assurance Engineer

This position involves leading quality-related activities, including risk assessments, device testing and validations, internal and external audits, and management of design history files.

  • Risk assessments are a critical component of this role.
  • Device testing and associated validations are necessary to ensure product safety and efficacy.
  • Internal and external audits help identify areas for improvement and ensure compliance with regulatory requirements.
  • The generation and/or approval of technical documents is essential for the success of this position.
  • Effective management of design history files is crucial for maintaining accurate records and facilitating regulatory submissions.
Key Responsibilities:

Some key responsibilities include ensuring compliance with regulatory requirements, collaborating with product development teams to translate user needs into design requirements, executing design verification, validation, and test method validation activities, partnering with R&D and Manufacturing Engineering to translate design requirements into manufacturing specifications, and leading resolution of project issues by applying structured problem-solving methodologies.

Essential Skills & Experience:

To be successful in this role, you will need a Bachelor's degree in Engineering, Science, or related technical discipline, as well as a minimum of 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, ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards is also required.

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