Quality Operations Engineer - 4-Shift Manufacturing

Abbott Laboratories; Ireland; Remote; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business

Job summary

Abbott in Kilkenny is seeking an Operations Quality Engineer to help analyse quality standards, support manufacturing, and ensure compliant, on-time delivery of products across the Diabetes Care site. This is a shift-based role on a 4 cycle shift, offering a dynamic environment and opportunities for professional growth.

You will apply quality principles across components, materials and processes, perform inspections, liaise with vendors and drive CAPA and improvements in a fast-paced healthcare

Qualifications

• Minimum NFQ Level 7 qualification in Engineering or Manufacturing.
• At least 3 years in a Manufacturing / Science or Engineering environment.
• GMP/GDP experience.
• ISO 13485 experience.
• Yellow belt qualification desired.

Responsibilities

• Apply quality principles, analyse quality records, prepare reports and recommend improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Identify and address recurring problems in product quality or testing procedures.
• Document quality issues and performance measures for management review.
• May liaise with external vendors.
• Monitor and maintain validation status of site products, processes and systems and monitor FMEA and CQAs.
• Maintain site validation plans and periodic review process.
• Support Equipment and Software validation activities and Process validation activities; provide updates to project peers.
• Report on and support actions to reduce non-conformances and initiate CAPA requirements.
• Present and communicate status, metrics, trends, issues and improvements.
• Investigate customer complaints and route reports to PQA group; maintain CAPA.
• Ensure teams use risk management tools to prioritise activities and justify effort.
• Monitor and maintain quality records and ensure project records comply with Quality System.
• Support DMR change control and calibration activities.

Education

NFQ Level 7 Qualification in Engineering or Manufacturing

Job description

Abbott in Kilkenny is seeking an Operations Quality Engineer to help analyse quality standards, support manufacturing, and ensure compliant, on-time delivery of products across the Diabetes Care site. This is a shift-based role on a 4 cycle shift, offering a dynamic environment and opportunities for professional growth.

You will apply quality principles across components, materials and processes, perform inspections, liaise with vendors and drive CAPA and improvements in a fast-paced healthcare