Abbott Senior Quality Professional in Sligo, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Ireland Diagnostic Division – Sligo:
Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.
Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.
We currently have a vacancy for a Senior Quality Professional and this role will involve the following:
Major Duties and Responsibilities
General Area: Defines project goals and milestones. Responsible for timely project completion. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders. Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly. Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
Quality System Compliance: Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Risk Management: Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk. Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
EHS : Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimization are adhered to and improvements made where possible. Depending on Functional Area
Quality Compliance : Complete ownership to ensure site quality systems are aligned and compliant with any new regulations, including IVDR.
Provide leadership, ownership, clear direction and define priority during all activities in area of responsibility.
Promote awareness and ownership for area of responsibility to establish the function as a key quality system.
Provide SME support for assigned area of responsibility.
Lead cross functional teams to maintain a consistent and up to date approach to area of responsibility.
Act as an enabler to ensure site and Division compliance requirements are met
Excellent communication, team and organizational skills required.
Ability to use own initiative and be proactive in the management of assigned tasks to set and meet deadlines.
Ability to work co-operatively and effectively with others to establish and maintain good working relationships.
Ensure ability to influence and manage cross functional teams and represent the site as SME when required.
The position may also require communication with the following:
Contacts with all levels within the plant.
Contact with external suppliers.
Contacts with Abbott personnel at many levels, Division, Affiliate and other plants
Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Preferred experience in the Healthcare industry
Has a history of completing successful projects and driving positive compliance outcomes.
Receives little detailed or general direction.
Responsible for ensuring compliant documentation in area of responsibility.
Carries out tasks with little management oversight.
Decisions have long term impact, aligned with the organization strategy.
This position has direct impact on site compliance. Compliance issues may result if assigned activities are not carried out correctly.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org