Operations Quality Shift Lead

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

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs around 6,000 people across ten sites. We currently have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Sligo & Kilkenny and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Please note any offer of employment for this position isconditional upon the successful completionof a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.

This is how you can make a difference at Abbott:

As an Operations Quality Shift Lead, you will be responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process. May supervise inspection and test activities of operators. Performs function failure testing as well as physical defects. This is a shift role on 4 cycles.

Key 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.

Education and Experience

• 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

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.