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Senior Quality Assurance Specialist
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About Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
We have been operating in Ireland since 1946 and serve the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, we currently employ about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Our Operations Quality Engineers will Analyze 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.
- 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.
- Investigate customer complaints and forward reports to responsible group and maintain Corrective and Preventive Action programs.
- Maintain an appropriate balance of quality, compliance and business risk and ensure teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
- Maintain 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.
To succeed as an Operations Quality Engineer, you will require:
- A minimum NFQ Level 7 Qualification in Engineering or Manufacturing qualification.
- Three years in a Manufacturing / Science or Engineering environment.
- GMP/GDP experience.
- ISO 13485 experience.
- A Yellow belt qualification is desired.
We provide an attractive compensation package that includes competitive pay, family health insurance, excellent pension scheme, life assurance, career development and access to many more benefits.
