A Senior Quality Engineer with experience working in Medical Devices or Pharma Industries is required by CareerWise Recruitment for our Galway based client, to provide Technical Engineering expertise and Project leadership. Please contact Tom Devaney for more information.
Role of this position
- 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.
- Bachelor's (Level 8) 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
- 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.
- Travel up to 50%, domestic and international.
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)