Medical Devices JobsSenior Quality Engineer (Global)

  • GY51347
  • Permanent
  • Galway

Collins McNicholas

A leading Medical Device organisation is seeking a Senior Quality Engineer to join their business permanently. The Sr. Quality Engineer will be expected to provide support to Global Sites whilst being based full-time in Galway. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment. You will be reporting directly to the Quality Director.

Key Requirements (full spec available on request)

  • Supporting global sites whilst based full-time in Galway (up to 5% travel required)
  • Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.  Experience with FDA and ISO inspections and registration is a plus.
  • Actively participates in internal audits, management review and other activities covered 
  • Provide customer-related quality and regulatory inquiries support.
  • Compiles and writes training material and conducts training sessions on quality control activities
  • Lead and provide Project Management support as needed.
  • Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA. 
  • Direct support for FDA and ISO inspections and registration.
  • Process improvements.

What you need to have

  • Level 8 in either Science or Engineering is required.
  • 8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
  • Experience with FDA and ISO 13485 Certification inspections is a plus.
  • Audit experience, strong project management skills and continuous improvement experience is essential for this role.
  • Must be adept in the use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred). 
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
  • Must possess excellent verbal & written communication skills, which include but are not limited to, presentation, organizational and management skills.

Benefits

  • Annual bonus
  • Healthcare
  • Pension

For a confidential discussion and more information on the role, please contact Elaine Dolan

elaine.dolan@collinsmcnicholas.ie

(091) 706718

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