Abbott Director, Quality Engineering in Lake Forest, Illinois
At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Leads team of Quality Engineers to establish and continuously improve critical aspects of the Quality System to achieve business objectives, including all aspects of quality and reliability of diagnostic products, from design transfer to post-market surveillance. Ensures quality sub-systems and operational processes are established to manufacture products of the highest quality to exceed customer requirements and regulatory expectations.
Recruits, coaches, and develops organizational talent to elevate the quality and manufacturing organizations. Fosters a diverse workplace and entrepreneurial environment that enables all participants to contribute to their full potential in pursuit of organizational objectives and excellence. Provides general direction to staff of Quality Engineers and exempt Quality Specialists, supporting multiple functional areas including Quality, Operations, Supply Chain, etc. Keeps the organization's vision at the forefront of decision making and action. Demonstrates effective change leadership. Build strategic partnerships across the global manufacturing network to further departmental and organization objectives. Interacts internally and externally with executive level management, outside regulatory agencies, customers, and suppliers. Coordinates across functional areas, business units, sites, and 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 business segment of the company. Monitors and ensure compliance with company policies and procedures, as well as, global regulations and expectations (e.g. FDA, ISO, IVDD/IVDR, etc.).
Makes and executes operational decisions with a strategic perspective. Directs and controls the activities and budget of one or more functional areas, product groups, and/or operations. Establishes Quality Systems that are in compliance with regulatory requirements and meets 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. Communicates quality policies, strategies and procedures to the organization throughout written documents, presentations and discussions. Experience and knowledge of diagnostics products and governing regulations will be a key enabler for success in this role.
Bachelor's degree and 12+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.
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. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations; 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.
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