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Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18871

Our Client a major multinational based here in Galway are looking for a Quality Engineer for an exciting new project on a fixed-term contract.


The Role:

The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in Quality related projects.  

The Quality Engineer reports to the Senior Quality Engineer.


Responsibilities

  • Identifies problems and possible solutions and takes appropriate action to resolve them. Demonstrates skill in data analysis techniques.
  • Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues.
  • Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances. 
  • Investigation & appropriately documenting non-conformance & CAPA
  • Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
  • Drives business improvements through continuous improvement initiatives.
  • Escalation point for quality-related non-conformances and CAPAs.
  • Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. 
  • Drives compliance across departments and Business Units through communication and collaboration to ensure that Quality System requirements are met throughout
  • Supports assigned project teams by providing analysis and expertise throughout the project planning and implementation phases
  • Participate in internal and external audit

Requirements

  • Third-level qualification.
  • Minimum 3 years of experience in the medical device industry with progressively responsible positions including; Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
  • Awareness of relevant laws and regulations (e.g. MDR / IVDR / FDA)
  • Broad knowledge of engineering and technical applications applied in the development of medical devices & IVD’s useful.
  • Experience in supply chain / distribution / warehouse management / facility validation desirable
  • Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded decisions
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
  • Proficient with MS Word, Excel, PowerPoint, and the management of spreadsheets.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717