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.
We have 109,000 colleagues serving people in more than 160 countries.
Serving the Irish Market
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritional products.
In Ireland, Abbott employs around 6,000 people across ten sites.
Abbott Ireland Diabetes Care Division Donegal
The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management.
Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system.
Primary Function
The Tech QA Lead supports qualification and validation activities alongside a team of Quality Engineers/Processors to ensure the site delivers safe and effective products that meet customer needs while maintaining compliance.
Responsibilities Include
* Supporting the development and implementation of company-wide quality systems and policy compliance to worldwide regulatory requirements.
* Performing QA review and approval of validation lifecycle documentation.
* Supporting and supervising the change control process for QA Validations.
* Ensuring validation and qualification activities comply with internal requirements and applicable regulations and standards.
* Supervising the QA Validation team and liaising with key stakeholders.
* Performing and approving risk assessments related to validation activities.
* Preparing product quality and process data using statistical techniques.
* Acting as a QA Validation Subject Matter Expert (SME) in support of planned and unplanned changes.
* Leading and promoting Continuous Improvement initiatives within the department and division.
Requirements
Bachelor's Degree in Engineering/Manufacturing/Science preferred.
Minimum 5 years of experience in Engineering/Manufacturing/Scientific roles, with supervisory experience preferred.
Estimated Salary: $120,000 - $180,000 per year