Director Quality Assurance - Abbott : Job Details

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.

Job Title: Director Quality Assurance

The Director of Quality Assurance leads management teams and technical staff of multiple groups/functions within the business unit/product specific division Quality organization responsible for ensuring product safety, reliability, and quality. In this role, the Director will:

• Ensure that processes and staffing are appropriately developed and implemented to maintain the quality system.
• Set strategic vision/goals in alignment with site organization and division.
• Ensure compliance within the organization to all applicable internal requirements and external regulations.
• Establish quality systems and plans to assure the manufacture of the highest quality products to exceed customer requirements.
• Interface with outside regulatory agencies as an Abbott representative.

• 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.
• Creates an entrepreneurial environment.
• Provides general direction to managers, exempt specialists, and non-exempt support in various areas, groups, and/or operations.
• 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.
• Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors, and/or suppliers.
• Coordinates across functional areas, business units, and/or geographies in order to achieve company or area goals.
• Utilizes technical/professional knowledge and skills to establish, interpret, and execute company policies in a major segment of the company.
• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes and executes operational decisions with a strategic perspective.
• Directs and controls the activities and budget of one or more functional areas, divisions, product groups, and/or operations.
• Establish Quality Systems that are in compliance with regulatory requirements and meet business needs.
• Reviews, analyzes, and presents to senior staff and other groups the effectiveness of the Quality System.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Analyzes data, makes decisions, or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction).
• Communicates quality policies, strategies, and procedures to the organization through written documents, presentations, and discussions.
• Monitors progress of departments or units toward divisional and company goals; monitors all costs associated with assigned organizational unit; monitors company-wide indicators such as market share and profitability; monitors industry trends and external environment in areas relevant to the assigned organizational unit.
• Develops and/or identifies new work processes that will have broad applicability throughout the company; contributes ideas for improving work processes and achieving organizational goals; investigates and solves problems that impact work processes and personnel in multiple units or departments; develops and communicates a vision for a major segment of the organization.

• Bachelor's degree and 16+ years related work experience.
• Strong Quality Leadership function experience (3+ at Director level).
• Experience working with Class III devices.

• Master's degree preferred.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.