Quality Engineer – CAPA
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Job Summary
JOB DESCRIPTION:
About Abbott
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. Our 110000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics medical devices and nutritionals Ireland Abbott employs over 4000 people across nine sites. We have six manufacturing facilities located in Clonmel Cootehill Donegal Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Rapid Diagnostics is part of Abbotts Diagnostics family of businesses bringing together exceptional teams of experts and industry leading technologies. Our in-vitroDiagnostic Assay manufacturing site in Dundee has an exciting opportunity for a Quality Engineer CAPA to join the team.
MAINPURPOSE OF JOB
This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook.
Working as part of theProduct Support Team theCoordinatorCAPAis primarily responsible forproviding ownershipoversightand reportingofNonconformanceand Corrective and Preventive Action (CAPA) processes at Abbott Dundee.
ACCOUNTABILITIES
Ownership of theNonconformanceand Corrective and Preventive Action (CAPA)System.
Assistin the initiationprocessingand completion of QI/CAPA records in the electronic system.
ensuringrecordowners are assigned andtimelyresponses and approvals are provided in alignment with quality goals.
Assessing and documenting the impact of each Nonconformance event todeterminetherequirementand extent of investigation.
Lead meetings and communications for QI/CAPA updates information and concerns including chairing siteCAPAReview board.Communicate confidently and effectively with all levels of managementpeersand key stakeholders includingtimelyescalation of quality issues.
Responsible for collation of metrics and reporting onregularbasis in accordance with established procedures.
Support team in the delivery and oversight of CAPA training program.
Provide support and subject matterexpertiseduring audits and inspections.
Lead and/or contribute to continuous improvement initiatives and projects.
Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
Being aware of the policies as set out in the Abbott Employee Handbook and able to enact them as appropriate
Carries out other duties as and when requested by Line and or Department Manager
BASEREQUIREMENTS
Degree or equivalent preferably a life science subject area and/or
Experience in a regulated industry preferred.
Experience with a range of root cause investigations tools and techniques.
Competence with QI/CAPA processes
BACKGROUND
A practical understanding of immunoassay and clinical chemistry testing In-vitro Diagnostics (preferred)
Experience with an Enterprise Resource Planning System (ERP)
Experience with Electronic Document Management Systems (EDMS)
Experience with QI/CAPA Systems (Agile preferred)
Experience with ComplaintInvestigation systems (Helix preferred)
Proficient with MS WordExceland Power-Point.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United Kingdom > Dundee : 17 Luna Place
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
