Operations Quality Engineer – GMP Medical Devices

Abbott; Kilkenny; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Family health insurance

Life assurance

Fantastic new facility

Growing business plus access to many

Job summary

Abbott in Kilkenny is seeking an Operations Quality Engineer to analyze quality standards across components and materials, applying sampling methods and testing to ensure compliance. You will provide quality guidance to Manufacturing/Operations and Product Test to deliver on-time, in-full, cost-effective products for the business and customers.

The role is shift-based on a 4-cycle shift, with responsibilities spanning inspection, validation, CAPA, and collaboration with vendors.

Qualifications

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

Responsibilities

• Apply quality principles, analyses quality records, prepares reports and recommends improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Document quality issues and performance measures for management review.
• May liaise with external vendors.
• Monitor and maintain the validation status of site products, processes and systems and monitor and maintain process FMEA and Critical Quality Attribute systems. Maintain site validation plans and periodic review process. Support Equipment and Software validation activities and support Process validation activities.
• Provide regular updates to peers and colleagues on project resource requirements and ensure other quality functions are brought into project teams at appropriate points.
• Report on and support the implementation of actions to reduce the occurrence/reoccurrence of non-conformances within Manufacturing, Product Test and Incoming Material and initiating Exception Reports for discrepancies observed during inspection / testing & review activities.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
• Investigating customer complaints and forwarding reports to PQA group and responsible for maintaining Corrective and Preventive Action programs.
• Responsible for maintaining an appropriate balance of quality, compliance and business risk and responsible for ensuring teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
• Monitor and maintain the quality and compliance status of associated quality records and ensure project teams maintain project records in compliance with Quality System and planned requirements.
• Support DMR change control and calibration activities.

Education

Minimum NFQ Level 7 Qualification in Engineering or Manufacturing

3 years in a Manufacturing / Science or Engineering environment

GMP/GDP experience

ISO 13485 experience

Job description

Abbott in Kilkenny is seeking an Operations Quality Engineer to analyze quality standards across components and materials, applying sampling methods and testing to ensure compliance. You will provide quality guidance to Manufacturing/Operations and Product Test to deliver on-time, in-full, cost-effective products for the business and customers.

The role is shift-based on a 4-cycle shift, with responsibilities spanning inspection, validation, CAPA, and collaboration with vendors.