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Principal Quality Professional job in Charlotte at Abbott Laboratories

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Principal Quality Professional at Abbott Laboratories

Principal Quality Professional

Abbott Laboratories Charlotte, NC 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, nutritionals and 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, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford 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 been operating in Ireland since 1946.

Abbott Ireland Diagnostic Division - Longford:

Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.

In 2004, Abbott's operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.

The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.

Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

Job Description Summary:

This Quality Professional position is focused on supporting the implementation & maintenance of Core Laboratory's post-market surveillance reporting to meet the requirements for the In-Vitro Diagnostics Regulation (IVDR) into ADD's Quality System. Additionally, the Quality Professional for post-market surveillance reporting executes activities assigned to them, collating needed inputs for reporting, working collaboratively with a broad cross-functional team.

Main Responsibilities:

* Supports the implementation and maintenance of the effectiveness of the Quality System with respect to collation of data and generation of reports required to support post market surveillance reporting submissions, as assigned.

* Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures and report templates compliant with the new regulation with respect to post-market surveillance reporting.

* Uses critical thinking to provide solutions that are compliant, innovative and consistent with organizational objectives.

* Coordinates the assigned schedule associated with the accrual, assembly of post-market surveillance inputs ensuring accurate and timely submission. Supports the processes for acquiring, analyzing, interpreting and reporting Post Market Surveillance data necessary to support PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents, such as Risk Management Files (RMF).

* Partners with Vigilance, Regulatory Affairs, Clinical Affairs, product, instrument and software teams, Field Assurance, Marketing and manufacturing facilities to proactively plan for and complete PMS reports, ensuring needed data is gathered accordingly.

* Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.

Scope:

Receives general direction and exercises considerable discretion to work own detail or as part of a team. Recommends possible solutions.

Ensures compliant documentation, carrying out tasks relating to area of responsibility with management oversight.

Decision may have short and long term impact.

Education & Experience

Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

A minimum of 3 year's work experience in Quality or Technical or related field experience; less experience may be appropriate with advance degree.

Preferred experience in the Healthcare industry.

Demonstrated examples of completing successful projects and driving positive compliance outcomes.

Connect with us at www.abbott.com or [ Link removed ] - Click here to apply to Principal Quality Professional on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Recommended Skills

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