Quality Engineer

Location: Galway city, Galway, Ireland
Date Posted: 01-23-2018

Quality Engineer

Division:                              Quality
Reports To:                         Quality Manager
Location:                             Galway
Industry:                              Medical devices

Position Summary

The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Quality Management Systems and in moderately complex Quality related projects.    The Quality Engineer reports to the QA & RA Manager.
Duties and Responsibilities
  • Possesses and applies a broad and increasing knowledge of Quality, and its application within Alere, to the completion of moderately complex assignments.
  • Broad knowledge of the organization’s operations and practices to enable informed decisions in day to day operations and assignments.
  • 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. Identifies problems and possible solutions and takes appropriate action to resolve.  Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
  • 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. 
  • 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. 
Minimum Qualifications & Skills
  • Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
  • Third level qualification.
  • Minimum 5 years of experience in medical device industry with minimum 3 year of 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. CE/ FDA/ PAL)
  • Broad knowledge of engineering and technical applications applied in development of medical devices useful.
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