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High-Level Quality Assurance Specialist

2 weeks ago

Loch Garman, Loch Garman, Ireland beBeeQualityEngineer Full time €91,726 - €113,135

We are seeking a seasoned Quality Engineer with expertise in medical device and pharmaceutical industries to lead quality engineering activities, manage multiple projects, and ensure design control compliance.

Main Responsibilities:
  • Represent quality interests and concerns on project teams, driving collaborative efforts towards excellence.
  • Leverage risk management expertise to own Quality engineering activities for New Product Development (NPD) projects.
  • Balance concurrent projects and tasks, from product inception through launch and maintenance, ensuring timely delivery.
  • Evaluate design control compliance requirements for NPD projects, guaranteeing adherence to industry standards.

This role demands an individual who can independently manage multiple projects while effectively collaborating in team settings and consistently meeting deadlines. We seek a third-level qualified engineer or technical/science professional with a minimum of five years' experience in the medical device or pharmaceutical industries.

About You:
  • Third-level Engineer / Technical / Science Qualification
  • A minimum of 5 years of experience in the medical device or pharmaceutical industry is desirable
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
  • Attention to detail and adaptability
  • Dedication to excellence, flexibility
  • Problem-solving techniques with excellent organizational skills
  • Excellent interpersonal skills with the ability to work in a team environment and work under your own initiative to target and deadlines