This is a shift based role on 4 cycle shift.
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.
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 13485 experience
Yellow belt qualification desired.
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
Family health insurance,
Excellent pension scheme
Life assurance
Career Development
Fantastic new facility
Growing business plus access to many more benefits.
Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
- The base pay for this position is
- N/A
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
ADC Diabetes Care
LOCATION
Ireland > Kilkenny : Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS
WORK SHIFT
Ie - Kky4Cyc1 (Ireland)
TRAVEL
Not specified
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Not Applicable
