Operations Quality Engineer Shift at Abbott

Kilkenny, County Kilkenny, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

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

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

Skills

Key technologies and capabilities for this role

Quality AssuranceInspectionVerificationValidationSampling MethodsTesting MethodologyStatistical AnalysisManufacturing ProcessesQuality StandardsReport Preparation

Questions & Answers

Common questions about this position

What is the work schedule for this Operations Quality Engineer role?

This is a shift-based role on a 4 cycle shift.

What are the main responsibilities of the Operations Quality Engineer?

Responsibilities include applying quality principles, analyzing quality records, conducting inspections and validations, identifying recurring problems, documenting issues, monitoring validation status, supporting validation activities, and reporting on non-conformances.

Where is this job located?

The role is at Abbott Diabetes Care in Kilkenny, Ireland.

What salary or compensation does this position offer?

This information is not specified in the job description.

What skills or experience make a strong candidate for this role?

Strong candidates will have expertise in quality principles, inspection and validation methods, process FMEA, validation activities, and experience analyzing quality records and addressing non-conformances in manufacturing.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees