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