Device History Record Review Team Lead

4 weeks ago

Kilkenny, Ireland Abbott Full time

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 over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo 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.

Diabetes Care Kilkenny

Our new manufacturing facility in Kilkenny, opening in 2024, 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. 

As a Device History Review Lead you will be part of the site quality team. You will support the wider organisation by leading the development and maintenance of processes and procedures in relation to finished product release. You will also lead the team of reviewers, supervising the activities, and workload to ensure support is provided to meet the department and company goals.

Prioritize and coordinate resources ensuring the department and site objectives are achieved.

Provide effective leadership to all team members, including goal setting, performance evaluations, development planning, and performance management.

Spearhead a work environment that ensures all communications, interpersonal interactions and business behaviours are consistent with ADC values and the Abbott Code of Business Conduct.

Monitors daily work operations and provides direction and guidance to team.

Present and communicate status, report metrics, identify trends and potential issues and escalate to management any issues related to noncompliance, or failure to achieve agreed performance objectives.

Represent ADC to internal/external auditors and regulatory bodies on any matter relating to areas of responsibility. Ensure area of responsibility and process are audit ready at all times and all audits are supported from a resource and information request perspective.

Maintain the quality and compliance status of associated procedures, work instructions and training material.

Identify and implement initiatives for continuous improvement of the Quality System.

Ensure approaches to Quality and Compliance are consistently applied within the business and across the division.

Ensure effective communication with other staff and quality management to share information and support the attainment of ADC quality goals and business objectives.

Provide divisional level support and guidance as SME for area of responsibility.

When requested, accept any responsibilities, and perform necessary tasks to support the business and other QAC activities.

Proactively address Health and Safety concerns within the working environment in order to reduce hazards and risks.

Coach and mentor staff members on performance, training, and development needs.

Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.

Minimum 4 years’ experience in a similar role,

Previous experience in managing a team in a manufacturing environment.

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.

Abbott is an equal opportunities employer.

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