Sr. Project Leader - Design Assurance

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About the role

JOB DESCRIPTION: Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands, including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna®, to help get the nutrients they need to live their healthiest life. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: • Career development with an international company where you can grow the career you dream of. • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity As the Sr. Project Leader, Design Assurance , the Design Assurance Sr. Project Leader will assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market as well as cost effectiveness. 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. What You’ll Do • Prepares Quality documents and assures appropriate design review is conducted. • Monitors product, process, package quality performance and identifies quality-related issues and trends. Works with and provides direction to functional peers and operations to develop and implement corrective actions. • Works on problems of complex scope where analysis of situation or data requires review of defined factors. • Exhibits high level of technical competence in data analysis and product-related calculations. • Collaborates and provides leadership across the technical portion of the organization. • Identify/gain agreement on design criteria, negotiate compromises, balance quality with other criteria across all functional areas. Leads risk assessments required as part of product development, identifies mitigations and drives the implementation of mitigating actions. • Displays working knowledge of relationships between regulations, labeling, process and product. Encounters differing but recurring problems and/or duties, supports root cause analysis and problem resolution. • Displays working knowledge of global regulations and policies related to Abbott’s nutritional products and assures products meet regulations. • Assures that the design and testing for all Abbott Nutrition products are fully compliant with applicable regulations and Abbott policies. • Lead/support the training of Project Leaders and Associate Project Leaders within the team, and onboarding of new team members. Requirements • B.S. in a Science-related field (Food Science, Chemistry, Microbiology or other technical science area); Master’s degree a plus. • Proficient technical writing skills; able to effectively and concisely communicate issues. • Ability to effectively organize and communicate technical information. • Knowledge of applicable regulatory standards and requirements for infant formula and nutriti

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