A large Medical Device Organisation based in Galway is now seeking an experienced Senior Quality Engineer to join their business permanently. The Sr. Quality Engineer will be expected to provide support to Operations, interact with customers, and provide support for Engineering, Quality Systems, and Process engineering.
The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment.
Key Duties (full spec available on upon request)
- Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
- Actively participates in internal audits, management review, and other activities
- Provide customer-related quality and regulatory inquiries support.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Provide QE direction, analysis, and recommendations for Product Development to successfully launch new products into active production in a timely and cost-effective manner.
- Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE, and process validation.
- Lead and provide Project Management support as needed.
- Up to 20% travel may be required.
- Level 8 in either Science or Engineering is required
Experience with Lean Manufacturing and Six Sigma is desirable
- Minimum 5 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
- Salary is DOE
- Annual Bonus
- Full healthcare
Please contact Elaine Dolan for more info on;
091 706 718