Senior Quality Engineer

7 days ago

Loch Garman, Loch Garman, Ireland beBeeQuality Full time €70,000 - €85,000

Product Design Assurance Professional

This role is ideal for someone with a meticulous approach to quality, who can scrutinize product designs and ensure they meet the highest standards.

Key Responsibilities:

  • Collaborate closely with cross-functional teams, including design, manufacturing, regulatory affairs, and compliance.
  • Lead thorough risk assessments on new products, using FMEA tools to rigorously test designs.
  • Provide expert quality support across R&D, design, validation, and testing methods.
  • Review product documentation to guarantee compliance with ISO standards.
  • Conduct statistical analysis and DOE to optimize products and processes.
  • Support studies through different testing phases, ensuring product robustness.
  • Contribute to biocompatibility assessments, protocol writing, and method validation.
  • Engage in internal and supplier audits, driving continuous improvement.

Requirements:

  • Degree in Engineering, Science, or Technical discipline.
  • Minimum 5 years' experience in medical devices or pharmaceuticals.
  • Strong knowledge of risk management and regulatory compliance.
  • Experience with FMEA and other risk management tools.
  • Skilled in statistics, validation, and testing methods.
  • Proven ability to scrutinize and stress-test designs to ensure product reliability.
  • Strong communicator, able to work collaboratively and independently.

About this role

We are seeking a skilled professional to join our team as a Product Design Assurance Professional. This role is responsible for ensuring the quality and safety of our products throughout the design process.

Benefits

In addition to a competitive salary and benefits package, this role offers opportunities for professional growth and development in a dynamic and supportive environment.

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