Quality Engineer

Quality Engineer – Sligo – Permanent!
This job will suit a Quality Engineer with 2 – 5 years + industry experience in a similar role.
Medical device experience preferred but not essential!
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:

• Auditing experience a plus.
• Validation experience, including Sterilization, process, and packaging validations, beneficial.
• Understanding of ISO 14971 and cGMP.

Educational / Professional Requirements

• Minimum degree in Science or Engineering
• 2-5 years of a Medical Device environment
• A strong knowledge of ISO 13485, FDA regulations (21CFR 820), and MDR.

Position Details:
 

• Full-time, Permanent contract.
• Immediate start

Application:

Interested candidates should send CV and Cover Letter to Padraig Mulcair
padraig@cregg.ie
(061) 363 318