Senior Quality Engineer – Galway

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Job Description

Senior Quality Engineer job available in Galway. Working in a major manufacturer of Medical Device products you will focus on defining, implementing and maintaining and improving Quality System requirements in the form of Quality Assurance.

Job Responsibilities:

  • Supervise personnel within an area of the Quality Department. Take the lead in this area.
  • Develop and modify Procedures and other related procedures
  • Participate/support the Management Review Process
  • Provide reports/information to management on quality related issues and define and implement solutions to quality related issues
  • Participate in and lead cross-functional teams as directed by the Quality Manager
  • Participate in and lead internal/external audits as required
  • Ensure that product conforms to specification and control further processing, delivery on installation or non-conforming product until the deficiency or unsatisfactory condition has been corrected
  • Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies and initiate, recommend or provide solutions to product and Quality system related problems
  • Interface with other departments to ensure that Quality system requirements are adhered to
  • Participate in and initiate job-related training courses
  • Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees

Candidate Overview:

  • BEng/BSc Level 8 degree qualified with at least 5-7 years’ experience in a manufacturing organization
  • Medical Device/Healthcare Industry experience is desirable
  • Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
  • Knowledge of FDA and ISO compliance
  • Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
  • Ability to work well as part of team and also to lead a team
  • Strong communication, organizational and project planning skills.
  • Ability to write engineering documents, test protocols, FMEAs
  • Skilled in statistical methods (Hypothesis testing, SPC, sampling plans, Gage R&R, process capability and graphical analysis).
  • Able to analyze and chart data using MS Excel or Minitab
  • Previous Quality Auditor experience is desirable, or certification is an advantage
  • Experience in Design Quality is desirable. 

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Megan Warr

Recruitment Consultant 091 507515
  • Salary:Negotiable
  • Location:Galway
  • Type:Permanent
  • Category:Engineering