Senior Engineer

1 day ago

Limerick, Limerick, Ireland beBeeCompliance Full time

We are seeking a skilled professional to lead the development and implementation of our quality systems, ensuring compliance with regulatory requirements and delivering effective solutions for global product development.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and refine Cook Medical's Global Design Controls, Process Development, and Risk Management policies and procedures.
  • Interpret standards, regulations, and guidance documents to ensure compliance and develop tailored solutions.
  • Develop and maintain an understanding of applicable standards, regulations, and guidance documents affecting Design Controls, Process Development, and Risk Management.
  • Represent Cook Medical in internal/external audits, act on assigned audit responses/CAPAs, and monitor Design Controls, Process Development, and Risk Management CAPAs.
  • Participate in the development and deployment of training materials, coordinate training sessions globally, and drive consistency across Cook Medical in Design Controls, Process Development, and Risk Management approaches.
Requirements
  • Bachelor's Degree in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing, or Biomedical disciplines.
  • At least 5 years' experience working in R&D and/or New Product Development, Process Development/Manufacturing Engineering, R&D systems engineering – Design Controls, Process Development, and/or Risk Management, Quality Assurance/Quality Engineering.
  • Effective oral and written communication skills, excellent problem-solving abilities, and willingness to work in collaborative and independent environments.
  • Experience working in a global environment/global teams across many cultures and regions, managing complex projects/programs in an engineering environment.
About This Role

This role offers the opportunity to work on high-impact projects, collaborate with talented professionals, and contribute to the success of our organization. If you have a passion for quality, regulatory compliance, and process improvement, we encourage you to apply.

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