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, nutritional and branded generic medicines.
Our 109,000 colleagues serve people in more than 160 countries. We have a diverse range of healthcare products including diagnostics, medical devices and nutritional products.
About Our Presence in Ireland
We operate across ten sites in Ireland, employing around 6,000 people. We have manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny and Sligo, as well as a third-party manufacturing management operation in Sligo.
We also have commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
About Abbott Diabetes Care Division
The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management.
Our leading brands include the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system.
Job Role: Tech QA Lead - Abbott Diabetes Care Division
Main Responsibilities:
* Support qualification and validation activities alongside a team of Quality Engineers/Processors, ensuring the site delivers safe and effective products that meet customer needs while maintaining compliance.
* Implement Quality Validation objectives and ensure short-term and long-term quality goals are met.
Key Responsibilities:
* Develop and implement company-wide quality systems and policy compliance to worldwide regulatory requirements, including FDA QSRs, ISO13485 & IVDD.
* Perform QA review and approval of validation lifecycle documentation (URS, IQ, OQ) protocols and reports.
* Support and supervise the change control process for QA Validations, ensuring quality objectives and timelines are met.
* Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
* Supervise the QA Validation team and liaise with key stakeholders, ensuring validation timelines are met.
* Perform and approve risk assessments related to validation activities.
* Prepare product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
* Act as a QA Validation Subject Matter Expert (SME) in support of planned and unplanned changes.
* Ensure alignment of process across the division.
* Lead and promote Continuous Improvement initiatives within the department and division.
Requirements:
* Bachelor's Degree
* Relevant third-level qualification; Engineering/Manufacturing/Science preferred
* Minimum 5 years' experience in Engineering/Manufacturing/Scientific roles
* Supervisory experience preferred