Quality Engineer – Galway – Permanent!
This job will suit a Quality Engineer with 2 – 3 years + industry experience in a similar role
Strong focus on Calibration for this position!
Great opportunity for the right person!
Please contact me for a full job description or more detailed information on this role!
The client would like the employee to be proficient in:
- Product and Process Validation, including FMEA, DOE, Test Method Validation, sampling plan analysis, etc
- Risk Management for Medical Devices and associated tools
- Six Sigma Problem-Solving Methodologies/Process Improvement
- Change Control
- CAPA/ Non-Conformance Reports
- Technical Writing
The client would like this employee to have a working Knowledge of:
- FDA 21CFR, ISO 13485, ISO 14971, MDD, etc
- Use and Application of Statistical Tools
- Internal & Supplier Auditing
- External Audit facilitation such as NSAI, FDA, etc
- MS Project, MS Visio, Minitab, etc
Educational / Professional Requirements
- Bachelor’s degree in science-related discipline or equivalent
- 3+ years relevant experience working in medical device-related quality function
- QMS Auditor Certification desirable
For further information or a confidential discussion please contact Deirdre Sheehan