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 107,000 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.
PURPOSE OF THE JOB:
We are looking for a highly motivated individual to join the team as a PRINCIPAL QUALITY PROFESSIONAL in our Strategic Projects team to be based in Sligo or Longford. As an individual contributor; the function of the Principal Quality Professional is to develop and deliver Supplier Quality process improvement initiatives and act as a key representative for the Supplier Quality organization working on Division Projects & Programs.
Global Supply Chain Quality Assurance is responsible for providing Quality oversight of Reagent Third Party Manufacturers (TPM’s) and Suppliers to the ADD Reagent manufacturing sites.
- Manages Third-Party Manufacturer (TPM) inputs and outputs associated with the IVDR Program e.g. change notifications, quality agreements, design document approval, DMR approvals.
- Supports development of new ADD/TPM processes as a result of IVDR QMS changes.
- Supports co-ordination of IVDR activities within the SQA organisation to ensure priorities are understood and timelines are achieved.
- Collaborates with Supplier Quality personnel and Global Cross Functional Teams to develop solutions to quality process inefficiencies, compliance gaps and create new business tactics.
- Represents GSCQA on cross-functional projects with other functional leaders. Directly influences project direction and scope.
- Defines and improves processes at Division and Site level. Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions.
- Uses Project Management tools and methodologies to translate top-level project goals to specific project tasks, milestones and deliverables, and manages the plan to deliver projects consistently.
EDUCATION & COMPETENCIES:
- Degree in life science, engineering, or closely related discipline.
- At least 5 years work experience in Quality or Technical or closely related field in medical device or pharmaceutical industry.
- Good understanding of design and design control as it pertains to IVD or Medical Device manufacture.
- Good knowledge of regulations and standards affecting IVDs and Biologics.
- Functions well within a matrix organization, experience working with teams across global boundaries.
- Strong communicator and committed teamplayer.
- Good analytical and conceptual thinking. Innovative, challenges traditional thinking and acts as a change agent.
- Experience with project management and has a history of completing successful cross-functional projects and driving positive compliance outcomes.
Visit Abbott at https://www.ie.abbott/ and connect with us on Twitter at @AbbottNews.