ABBOTT LABORATORIES Project Leader Design Assurance - Quality - Nutrition - Columbus, OH Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Primary Function / Primary Goals / Objectives:

The Design Assurance Project Leader will work with product development teams to assure the quality, safety and efficacy of our products from development through commercialization.  The Project Leader needs to be team oriented, agile, innovative and able to anticipate and mitigate risks. The Project Leader delivers timely, fact based, decisions focused on assuring quality products.  

The successful candidate works with their functional group peers and managers to define Design Assurance related deliverables to ensure successful scale up to commercial scale manufacturing (successful FLTS process). Together with R&D, Technical Centers and Plant operations, the incumbent assesses critical quality attributes and ensures the manufacturability of new formulations and products.

Major Responsibilities:

• Assures that the design and testing for all Abbott Nutritional products are fully compliant with applicable regulations
• Facilitates product technical risk management activities through product development stages
• Utilizes Food Science knowledge to assure design, evaluate risk and successful manufacture.
• Monitors product, process and package quality performance and identifies quality related issues and trends. 
• Works with and provides direction across multiple functions including Supply Chain, R&D, Operations, and Regulatory. 
• Prepares Quality documents and ensures accuracy of documents within Quality Systems.
• Works on problems of complex scope that can have significant business impact
• Identify/gain agreement on design criteria, negotiate compromises, balance quality with other criteria across all functional areas
• Displays working knowledge of relationships between regulations, labeling, process and product.