Quality Engineer – CAPA

Abbott; Dundee; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading global healthcare company in Dundee seeks an experienced Quality Engineer – CAPA to manage Nonconformance and Corrective and Preventive Action processes. In this role, you will be responsible for initiating and overseeing QI/CAPA records, leading meetings for updates, and supporting audits. Ideal candidates will hold a degree in a life science field and have knowledge of QI/CAPA protocols. This opportunity offers a chance to engage in continuous improvement initiatives in a regulated environment.

Qualifications

• Degree or equivalent, preferably in a life science subject area.
• Experience in a regulated industry preferred.
• Experience with root cause investigation tools and techniques.

Responsibilities

• Ownership of the Nonconformance and CAPA System.
• Initiate, process and complete QI/CAPA records.
• Lead meetings for QI/CAPA updates and concerns.
• Provide support during audits and inspections.
• Contribute to continuous improvement initiatives.

Skills

Knowledge of QI/CAPA processes

Root cause investigation tools

Proficient with MS Word

Proficient with Excel

Proficient with PowerPoint

Education

Degree in life science subject

Tools

Enterprise Resource Planning System (ERP)

Electronic Document Management Systems (EDMS)

QI/CAPA Systems (Agile preferred)

Complaint Investigation systems (Helix preferred)

Job description

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 110,000 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 products. In Ireland, Abbott employs over 4,000 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

Abbott Rapid Diagnostics is part of Abbott’s 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.

MAIN P URPOSE 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 the Product Support Team, the Coordinator, CAPA is primarily responsible for providing ownership, oversight and reporting of Nonconformance and Corrective and Preventive Action (CAPA) processes at Abbott Dundee.

ACCOUNTABILITIES

• Ownership of the Nonconformance and Corrective and Preventive Action (CAPA) System.

• Assist in the initiation, processing and completion of QI/CAPA records in the electronic system.

• ensuring record owners are assigned, and timely responses and approvals are provided in alignment with quality goals.

• Assessing and documenting the impact of each Nonconformance event to determine the requirement and extent of investigation.

• Lead meetings and communications for QI/CAPA updates, information, and concerns, including chairing site CAPA Review board. Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

• Responsible for collation of metrics and reporting on regular basis in accordance with established procedures.

• Support team in the delivery and oversight of CAPA training program.

• Provide support and subject matter expertise during 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.

BASE REQUIREMENTS

• 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 Complain Investigation systems (Helix preferred)

• Proficient with MS Word, Excel and Power-Point.

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

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