Experienced Quality Professional Wanted

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000
Job Opportunity

We are seeking a highly skilled professional to fill the position of Senior Quality Engineer.

  • The ideal candidate will be responsible for providing quality support during in-house manufacture and lot release, developing quality plans, programs, and procedures for commercialisation, and ensuring all work is carried out in compliance with Quality, Regulatory, and company policies and systems.
  • This includes working across all stages of development, manufacture, and commercialisation, supporting the Quality Management System and collaborating with R&D, manufacturing, and regulatory teams to ensure device compliance with user, regulatory, and ISO 13485 requirements.

Key Responsibilities:

  • Quality Support
  • Developing Quality Plans
  • Ensuring Compliance

Requirements

The successful candidate should have a Bachelor's degree in a relevant Engineering or Science field, 5 years' experience in the medical device industry, and project planning, communication, and writing skills. Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) is essential, while cleanroom and sterilisation experience, as well as process validation experience, are preferred.

  • Bachelor's degree in a relevant Engineering or Science field
  • 5 Years' experience in medical device industry or equivalent higher-level postgraduate study (masters or PhD)
  • Project planning, communication, and writing skills
  • Sound understanding of engineering fundamentals
  • Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820)
  • Cleanroom and sterilisation experience (preferred)
  • Process validation experience (preferred)

About This Role

This role offers a challenging opportunity for a motivated individual to make a significant contribution to our organisation. The successful candidate will have the chance to develop their skills and expertise in a dynamic and supportive environment.

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