Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Clara Burke
email science@hero.ie

Senior Quality Engineer

Job ID: JOB-11720
Senior Quality Engineer

A leading medical device manufacturer is recruiting for a Senior Quality Excellence Engineer to join their Galway site on a permanent basis.

As a Senior Quality Excellence Engineer, you will be a key member of the Global Quality OpEx Team. You will provide technical engineering expertise and project leadership for the Interventional Vascular – Structural Heart and Active Implantables & Pumps Operating Networks.

Responsibilities

  • Identify and execute Quality projects related to line efficiency, inspection removal/automation, Cost of Poor Execution (COPE), and SOGL reduction.
  • Deploy and monitor First Time Quality (FTQ), Inspection to Assurance (I2A), and Quality Begins with Me (QBwM) across the manufacturing networks.
  • Develop, implement, and maintain technical quality assurance and control systems for materials, techniques, and products.
  • Oversee the investigation and evaluation of inspection automation technology.
  • Guide the conceptualization of new methodologies, materials, machines, processes, and products.
  • Manage feasibility studies of the design, specifically manufacturability (DRM), to determine if capable of functioning as intended.
  • Monitor documentation maintenance throughout all phases of research and development.

Key Skills & Experience

  • Bachelor’s degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.
  • 5+ years’ experience in medical device manufacturing, pharmaceuticals, or other regulated industry.
  • Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.
  • Experienced practitioner of Design for Reliability and Manufacturability (DRM) and/or Design for Six Sigma (DFSS) with DRM/DFSS Green or Black Belt.
  • Experienced practitioner of continuous improvement methodologies with Lean Six Sigma Green or Black Belt.
  • Advanced statistical data analysis skills.
  • Experience working with cross-functional and international teams.
  • Ability to manage multiple projects across multiple geographies.
  • Able to work independently, as well as in a team environment.
  • Ability to educate stakeholders, customers, and management.
  • Travel up to 50%, domestic and international.

For more information on this role in Galway please contact Clara Burke on 0868168273/ science@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

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Clara Burke

JOB-11720

Senior Quality Engineer

Clara Burke

Role Type Permanent
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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