This is an exciting opportunity for a Quality Engineer to join a leading global medical device company based in Cork.

Key Roles & Responsibilities:

Supervision of Quality Technicians.
Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, and Process Automation activities).
Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in the process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
Drive and implement plant wide quality system improvements.
Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
MRB: Review of MRB trends and identification of appropriate corrective actions when required.
Perform internal quality audits.
Support the implementation of Lean Manufacturing across the site.

Education & Experience:

Minimum of Bachelor of Science Degree in Engineering/Technology.
2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
Experience in the medical device industry is an advantage.
Experience on an automated/high-volume line is an advantage.

For a confidential discussion and more information on the role, please contact Kevin Griffin

Kevin Griffin

(021) 2427108

Quality Engineer