Senior Product Reliability Specialist

2 days ago

Loch Garman, Loch Garman, Ireland beBeeQuality Full time €80,000 - €100,000

Job Title: Design Quality Engineer

Job Description

This role involves working closely with design, manufacturing, regulatory affairs and compliance teams. The successful candidate will be responsible for leading risk assessments on new devices using FMEA tools to stress-test designs.

They will provide quality support across R&D, design, validation and test methods. Reviewing design documentation to ensure compliance with ISO, ISO and CFRs is also a key part of the job.

The ideal candidate will have experience with statistical analysis and DOE to optimise products and processes. They will also support studies through different testing phases ensuring design robustness.

Responsibilities include contributing to biocompatibility assessments, protocol writing and method validation. Engaging in internal and supplier audits driving continuous improvement is also required.

Required Skills and Qualifications

  • 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 (FMS experience an advantage)
  • Skilled in statistics, validation and test methods
  • Proven ability to challenge and stress-test designs to ensure product robustness
  • Strong communicator able to work cross-functionally and independently

Benefits

  • Flexitime with Monday-Thursday on site in Enniscorthy and Friday morning from home
  • Join a dynamic multidisciplinary team working at the interface of design quality and compliance
  • Exposure to cutting-edge development across multiple testing phases
  • A varied role where no two days are ever the same
  • Competitive salary and benefits package

What We're Looking For

Our client is seeking a highly skilled and experienced Design Quality Engineer to join their expanding team. If you have a passion for delivering high-quality products and are looking for a challenging and rewarding role then this could be the perfect opportunity for you.

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