Quality Engineer with at least 3 years experience in a quality engineering role & experience in the medical devices sector required for permanent role with growing company in South Dublin

Key Responsibilities:

  • Support product design and manufacturing activities
  • Represent Quality through all product and process development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
  • Provide advice based on R&D’s objectives
  • Review engineering specifications to ensure QA requirements are met
  • Make sure that equipment and process validations meet FDA and EU regulatory requirements
  • Prepare reports, documents, procedures, specification’s and other such technical documents as required to ensure the success of the project
  • Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification

 

Requirements: 

  • Bachelor’s Degree in engineering or a related field
  • 3+ years’ experience in a quality engineering role
  • Experience in a quality engineering role in the medical device industry
  • Experience of validating processes to medical device regulatory requirements
  • Project management experience
  • Knowledge of analytical and statistical techniques, including SPC and inspection and test methodologies
  • Ability to develop and write protocols, validation reports and engineering reports
  • Competent working knowledge of recognized Quality Management Systems (e.g. ISO13485)
  • Awareness of relevant laws and regulations (e.g. MDD/ FDA/ PAL)
  • Broad knowledge of engineering and technical applications applied in the development of medical devices useful

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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