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.
- 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/ email@example.com
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