JOB DESCRIPTION:
About Abbott
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Ireland
In Ireland, Abbott employs over 5,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Global Supply Chain Quality Assurance is responsible for providing Quality oversight of Reagent Third Party Manufacturers (TPM’s) located across the Globe.
We are looking for a highly motivated individual to join the team as a PRINCIPAL QUALITY PROFESSIONAL based at either the Sligo or Longford Core Diagnostics sites. The successful individual will work with TPM suppliers and internal stakeholders to ensure products continue to be safe and effective.
Major Responsibilities:
- Collaborate with colleagues in Technical, Regulatory, Quality, Planning, Engineering and Operations to perform product changes, non-conformances, quality agreements, product/process improvements & product launches in partnership with assigned TPMs.
- Build effective working relationships with assigned TPM’s and globally based colleagues to enable successful problem solving.
- Represent GSCQA on cross-functional projects with other functional leaders, with internal manufacturing sites, TPM organisations and suppliers.
- Prepare TPM audit documentation and work with Core Dx auditing team to ensure sufficient oversight of TPM partners.
- Support External and Internal audits of Abbott LM sites responsible for TPM products.
- Complaint Evaluation/CAPA: Investigate complex issues & coordinate quality decisions in collaboration with other functional areas such as PQA, Medical Affairs and TPM Technical. Interface with suppliers to deliver product meeting our quality requirements.
- Lead projects and priorities using a structured approach to ensure successful and on time delivery of assigned projects.
Education & Experience
- Bachelor’s Degree in life science, chemistry, engineering or closely related discipline.
- At least 6 years work experience in a Quality or Technical role within the IVD industry. Less experience may be appropriate with an advanced degree.
- Good knowledge of regulations and standards affecting IVDs
- Experience in one or more key quality processes such as Supplier Control, CAPA, Complaints/Field Actions/Post Market Surveillance, Design Control or Testing.
- An understanding of IA/CC assays, and manufacture of same would be advantageous.
Key Skills
- Able to perform well within a matrix organization, and 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.
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:
HIAC Core Lab
LOCATION:
Ireland > Sligo : Finisklin Road
ADDITIONAL LOCATIONS:
Ireland > Longford : Lisnamuck
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Not Applicable