Quality Assurance Manager
Abbott
**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 1946 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.
Connect with us at www.abbott.com and on LinkedIn , Facebook , Instagram , X and YouTube .
**Purpose Statement**
You will provide management of a functional area that results in the implementation and achievement of vision, mission and functional objectives. You will be responsible for overseeing and directing Quality Engineering, Supplier Quality Engineering, Regulatory Compliance, Analytical laboratories, Product release and quality Control functions, as required, to support Manufacturing, Supplier Development, New Product Development and Quality Systems.
You will plan, develop and manage the quality organization to assure the continuance of qualified and efficient staff to meet Corporate, Food and Drug Administration (FDA), International Organization for Standardization (ISO) requirements as well as other regulatory requirements as captured in COP381.
You will ensure the overall compliance and effectiveness of the quality system with established requirements and quality system regulations.
You will direct projects to ensure the manufacture of high-quality product and to facilitate compliance with requirements.
You will evaluate performance of direct reports and supports career development activities. You will ensure that program and project objectives are met, budgets are adhered to and metrics are captured and published.
**Key Responsibilities**
+ Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
+ Keeps the organization’s vision and values at the forefront of decision making and action.
+ Demonstrates effective change leadership Builds strategic partnerships to further departmental and organizational objectives.
+ Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
+ Makes decisions regarding work processes, operational plans and schedules in order to achieve department and site objectives.
+ Develops, monitors and appropriately adjusts the annual budget for the areas of operation. Participates with manufacturing management at all levels in problems relating to quality, compliance and reliability.
+ Oversees the completion of the annual product review as requested. Establish and maintain effective structures to ensure consistent implementation of the quality system for Abbott Vascular (AV) Clonmel as the site of legal manufacture.
+ Monitors compliance with company policies and procedures (for example (e.g.) compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Equal Employment Opportunity (EEO) regulations and standards, etcetera (etc.)) and escorts inspectors/auditors for third party and unannounced inspections/audits.
+ Approves documents defining the quality system and can own documents. Coordinates where required audits by external bodies to the site and supports audits as requested across the division.
+ Ensures where applicable that the internal audit schedule is executed in a timely and effective manner.
+ Drives continuous improvement/ Corrective Action Preventive Action (CAPA) and validation initiatives.
+ Ensures that valid test data is used for all regulatory submissions. Responsible for development and execution of a robust supplier evaluation and monitoring programme ensuring that quality materials and services are used onsite; achieve through periodic assessment and communication of supplier performance.
+ Responsible for reviews of subcontractors, suppliers and service providers quality systems to ensure that purchased product fully complies with the specified requirements.
**Education & Job Skills**
Experience/Education: National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 9+ years of related work experience or an equivalent combination of education and work experience.
**Set Vision & Strategy:**
Identifies and acts upon trends that can impact the business. Creates and communicates a motivating compelling vision of the future that supports employee engagement. Develops short and long-term strategies and helps align the resources to achieve them. Translates strategies into actionable goals and plans and then communicates them to ensure alignment of effort and purpose.
**Anticipate:**
Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. Takes initiative to implements change before others. Actively gathers customer inputs in order to anticipate and fulfil their needs and requirements. Manages internal/external stakeholders to identify and address issues. Understands the situation or audience and adjusts approach to achieve desired outcomes.
**Innovate:**
Creates and environment of experimentation and uses failure as an opportunity to learn and take alternate action.
**Challenges current thinking:**
Generates new ideas and expects others to do the same. Integrates information from multiple sources to generate unique insights or new solutions that distinguish Abbott from the competition. Leverages diversity of people and thinking to create a competitive advantage. Collaborates across boundaries to create cross-business opportunities.
**Build:**
Creates a sustainable infrastructure and environment that enables growth. Maintains leadership presence and emotional control in difficult situations. Provides the insight, knowledge and leadership to improve functional are and builds the business. Develops, rewards and shares talent; is the type of leader others want to work with or for. Provides accurate, frequent and constructive feedback to subordinates, peers and leaders. Makes the difficult people, financial and business decisions in a timely manner.
**Deliver Results:**
Displays continuous energy, intensity and persistence to drive the organization forward. Delivers what is promised; holds self and others accountable for results, commitments and behaviors. Takes appropriate accountability for failure; does not blame others. Takes action in a timely manner, with urgency or caution as appropriate, but always in a planned way. Balances short and long-term priorities and maximizes the opportunities for both. Addresses organizational or cultural barriers that could prevent success.
**Supervision Received:**
Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.
**Supervision Provided:**
Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; evaluates performance of and assists in career development planning for subordinates often responsible for a centralized staff or professional function of the company.
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 corpjat@abbott.com
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