Senior Quality Engineer

2 weeks ago


Galway, Galway, Ireland beBeeQuality Full time €65,000 - €95,000

Job Description:

This is an exciting opportunity to work as a Quality Assurance Specialist in the medical device sector. As a key member of our team, you will be responsible for ensuring product quality throughout the development phases.

Key Responsibilities:

  • Ensure compliance with relevant policies and procedures
  • Lead and support quality control activities including CAPA, audits, and supplier management
  • Apply problem-solving methodologies to identify, prioritize, and resolve quality issues
  • Plan, execute, report, and follow up on quality system audits

Requirements:

  • Degree in quality engineering, life science or related field
  • 3-5 years experience in a quality assurance role in the medical device sector
  • Quality certification and lead auditor certification an advantage
  • Knowledge of FDA's 21 CFR Part 820 and ISO 13485:2016

Skills and Qualifications:

  • Experience in QA activities associated with design and development of medical devices
  • Results-driven with ability to handle multiple tasks and operate in a fast-paced environment
  • Excellent interpersonal skills and ability to work effectively as part of a team
  • Excellent written and communication skills, fluency in English


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