QA Technical Lead

4 days ago

Donegal, Ireland Abbott Full time

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,nutritionaland branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medicaldevicesandnutritionalproducts. In Ireland, Abbott employs around 6,000 people across ten sites. We have manufacturing facilitieslocatedin Clonmel,Cootehill, Donegal, Longford, Kilkenny and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have beenoperatingin Ireland since 1946.

Abbott Ireland Diabetes Care Division Donegal

The Abbott Diabetes Care division based in Donegal Town manufacturesFreeStyleblood glucose test strips andFreeStyleSensors for use in diabetes management. Among Abbott Diabetes Care leading brands are theFreeStylePrecision,FreeStyleLite andFreeStyleLibre system

Primary Function

The main responsibility of the Tech QA Lead is to support qualification and validation activities alongside a team of Quality Engineers/Processors, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance. Responsibility of implementing Quality Validation objectives and ensuring short-term and long-term quality goals are met.

Responsibilities Include

Support the development & implementation of company-wide quality systems & 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.

Ensuring alignment of process across the division.

Lead & promote Continuous Improvement initiatives within the department and division.

Education and Years Experience

Bachelors Degree

Relevant third level qualification. Engineering/Manufacturing/Science is preferred.

Minimum 5 years in Engineering/Manufacturing/Scientific.

Supervisory experience preferred

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