Quality Assurance Specialist

2 days ago

Enniscorthy, Loch Garman, Ireland beBeeQuality Full time €43,000 - €73,600
Job Title

A Quality Engineer is needed to ensure the highest-quality products are manufactured.

This role involves ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects. The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. They are responsible for reviewing design compliance, conducting statistical analyses, and initiating corrective actions when necessary. This position also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R.

Main Responsibilities:

  • Representing quality interests on project teams
  • Leading quality engineering tasks and risk management activities
  • Reviewing design control compliance requirements
  • Developing UFMEA & DFMEA
  • Performing DOE's and other statistical analysis
  • Supporting assessment of Biocompatibility testing
  • Participating in internal audit and supplier audit programmes

About You:

  • Candidates should have a third-level qualification in engineering, science, or a technical field
  • Minimum of five years of experience in the medical device or pharmaceutical industries is desirable
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR

We Offer:

  • A competitive salary range from €43,000 to €73,600 per year
  • A dynamic work environment with opportunities for growth and development
  • A comprehensive benefits package, including health insurance and retirement savings plan

Why Join Us?

We are committed to fostering an inclusive, growth-centered, and rewarding culture. Our team works collaboratively to achieve our goals, and we strive to make a positive impact on our customers and communities.

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