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 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland Abbott has been operating in Ireland since **** and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products.
In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.
PURPOSE OF ROLE In this role you will be responsible for leading and managing the Supplier Quality Assurance (QA) team, providing robust quality oversight to Third-Party Manufacturers (TPMs) and suppliers to ensure the consistent delivery of compliant products.
This includes managing TPM relationships where suppliers are responsible for procuring, assembling, testing, accepting, and packaging products for distribution.
The role ensures suppliers apply and document appropriate engineering and quality approaches, including qualification and validation activities, and provides guidance and support where required.
In addition, the position oversees the evaluation and approval of supplier-initiated changes or improvements, including the identification and approval of alternate materials or new suppliers.
A key focus of the role is maintaining audit readiness, ensuring the area is prepared for both internal and external Quality System audits.
MAIN RESPONSIBILITIES Manages a staff of Supplier Quality Engineers in order to support the supplier management program for the business.
Lead a team of quality professionals ensuring that all communications, interpersonal interactions and business behaviors are consistent with Abbott's Code of Conduct and Core Values.
Identify and support staff learning and development needs.
Mentor, coach and develop team.
Maintaining approved status for all AVL suppliers.
Developing and maintaining supplier qualification plans.
Diligent and Compliant execution of the Supplier Change Management program.
Work with suppliers to align their quality systems with the sites quality requirements both through continuous improvement initiatives and in response to material and service non conformances.
Responsible for agreeing to the appropriateness of all associated non-conformance CAPA plans.
Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits).
Leads projects, as related to supplier quality and department initiatives.
Leads improvement projects, as required, to improve supplier performance.
Effective communication networks are established with key stakeholders, in particular with Divisional Supplier QA to deliver aligned supplier management strategy.
Supports in the selection, approval and maintenance of approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.
Work closely with multiple functions including Technical Engineering, Research and Development Functions, Operations, Regulatory Affairs in order to ensure changed or new product/processes are implemented in compliance withthe site, Corporate and cGMP requirements, and in a timely manner to ensure business goals are met.
Must utilize problem solving skills with limited guidance /oversight to fit the business and quality needs.
Ensure that quality/compliance issues are highlighted and Quality decisions are made in a timely manner to facilitate new/changed product supply.
Work with the Operations team to ensure the successful, compliant guidance on product, process, equipment, analytical which may or may not require a re-validation.
Ensure that all of the members of the department stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents.
Support a work environment that ensures team effectiveness.
Coach and mentor team members on performance, learning and development needs.
Ensure effective communication with other staff and Quality Management to share information and support the attainment of quality goals and business objectives.
Manage the Department budget to ensure spending is within agreed limits.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.
Monitors supplier performance and reports supplier quality trend data to upper management.
Supports supplier continuous improvement plans and activities.
Ensure that all actions and instructions are consistent with the site EHS policy, procedures and best practices; promote awareness of EHS issues and proactively help to reduce hazards and risk within the department.
Minimum Requirements Bachelors Degree in Science, Engineering or equivalent 9+ years Quality Assurance experience in the medical device or pharmaceutical or other quality managed industries Extensive knowledge of applicable regulations, such as FDA QSR, ISO, MDD,