Quality Professional – Legal Manufacturer Support

Job description

JOB DESCRIPTION:

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 113,000 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 5,000 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 Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

Job Description Summary:

This Quality Professional position is focused on supporting the establishment of ARDx ID Galway as a legal manufacturer entity for select on-market and new products. Additionally, this role is focused on supporting the implementation & maintenance of ADRx’s Quality System in alignment with applicable regulations and standards including ISO 13485, FDA 21 CFR 820 etc. The Quality Professional leads activities assigned to them, collating needed inputs and working collaboratively with a broad cross-functional team.

Main Responsibilities:

·  Provide support to the implementation of the applicable quality system at ARDx ID Galway.
·  Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and NPI, as assigned.
·  Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
·  Support and/or lead the review and approval of quality system procedures and design records.
·  Support and/or lead the development and update of associated Risk Management files.
·  Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
·  Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
·  Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
·  Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.

Scope:

·  Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
·  Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.

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

Experience:

·  At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.
·  Preferred experience in the Healthcare industry.
·  Has a history of completing successful projects and driving positive compliance outcomes.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable