How you can make a difference at Abbott
As an Operations Quality Engineer you will Analyse quality standards for components, materials or services.
Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.
Provide Quality expertise and guidance to Manufacturing/Operations, Technical/Product Test and Incoming Materials to support the manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers.
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 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.
Qualifications and Experience
Minimum NFQ Level 7 Qualification in Engineering or Manufacturing qualification
3 years in a Manufacturing / Science or Engineering environment
GMP/GDP experience
ISO ***** experience
Yellow belt qualification desired.
What we Offer
Family health insurance
Excellent pension scheme
Life assurance
Career Development
Fantastic new facility
Growing business plus access to many more benefits.
Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.
Abbott is an equal opportunities employer.
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