Abbott Sr. Project Leader Design Assurance - Columbus Ohio in Columbus, Ohio

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.

The Design Assurance 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 to quality attributes and ensures the manufacturability of new formulations and products.

This position reports to the Manager, Global Design Assurance. Ensures that all Abbott Nutrition products meet the highest standards for quality required by regulations and is responsible for determining trends in the supply chain and adapting or transforming quality processes to achieve breakthrough improvements. Interruption in the distribution of products can result if these efforts are not well planned and coordinated across the business.

Major Responsibilities

  • 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

  • Displays working knowledge of relationships between regulations, labeling, process and product. Encounters differing but recurring problems and/or duties.

  • Displays working knowledge of global country regulations and policies related to Abbott’s nutritional products and assures products meet regulations and infant formulas meet all IFA regulations.

  • Assures that the design and testing for all Abbott Nutritional products are fully compliant with applicable regulations. Education:B. S. in Science Related field (Food Science, Chemistry, Microbiology or other technical science area); Master’s degree a plusBackground

  • 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 nutritional products.

  • Knowledge of quality management systems and regulatory requirements.

  • The incumbent must have the ability to work and interact with many cultures in many time zones, and be capable of interpreting and analyzing technical data from different regions for decision making.

  • Ability to work independently and/or function with minimal supervision.

  • Must be able to maintain a high degree of accuracy and analytical thinking.

  • Minimum 3-5 years working experience in the food/nutritional industry and experience in the scale- up and commercialization of product innovations.

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