Quality Operations Lead - Manufacturing Shift

Abbott Laboratories; Kilkenny; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career development

Fantastic new facility

Growing business plus benefits

Job summary

Abbott Laboratories in Kilkenny is hiring an Operations Quality Shift Lead to supervise manufacturing inspection and test functions across all stages. You will guide quality assurance activities, manage a team of quality engineers, and drive compliance, safety, and continuous improvement within the site.

You will coordinate with R&D, Engineering, and Regulatory Affairs to meet project goals, lead audits, and champion a right-first-time quality culture. Requires GMP/GDP and ISO13485 experience.

Qualifications

• A minimum of a NFQ Level 7 Qualification in Science / Engineering or Manufacturing qualification.
• Minimum of 4 years’ experience in Manufacturing.
• Minimum 2 years’ experience people management.
• Yellow belt qualified desired.
• Strong communication and organisation skills.
• Strong problem solving.
• Experience with GMP/GDP.
• ISO13485 experience.

Responsibilities

• Oversees operational implementation of quality assurance strategies and regulations.
• Completes the assessment of potential risks, ensures compliance, and gives recommendations to management.
• Supervises team to ensure quality control aspects of the process are met (laboratories studies,clinical research, testing, operations, raw materials, production, finished product or services).
• Facilitates audits and regulatory inspections.
• Liaises with external vendors, contractors, or suppliers to ensure that their products or services meet the organisation's quality standards.
• Lead a team of Operations Quality engineers.
• Manage functional area’s compliance to site and divisional policies and procedures.
• Lead the continuous improvement and effective maintenance of the QMS.
• Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required.
• Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals.
• Manage teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.
• Act as Lead for the monitoring and compliance of the Quality Management System as it applies to site Operations:
• Lead team in making Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging.
• Lead audit readiness in functional area
• Identify and lead projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
• Champion a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities.

Skills

Quality assurance

Regulatory compliance

Risk management

Team leadership

GMP/GDP

ISO13485

Communication

Problem solving

Education

NFQ Level 7 qualification in Science/Engineering or Manufacturing

Job description

Abbott Laboratories in Kilkenny is hiring an Operations Quality Shift Lead to supervise manufacturing inspection and test functions across all stages. You will guide quality assurance activities, manage a team of quality engineers, and drive compliance, safety, and continuous improvement within the site.

You will coordinate with R&D, Engineering, and Regulatory Affairs to meet project goals, lead audits, and champion a right-first-time quality culture. Requires GMP/GDP and ISO13485 experience.