Project Leader, Design Quality Assurance

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 109,000 colleagues serve people in more than 160 countries.

Nourish the world and your career as part of the Nutrition team at Abbott.

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®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.

Our location in Columbus OH, currently has an opportunity for a Project Leader, Design Quality Assurance. The role resides within the Quality organization and will work closely 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 will deliver timely, fact-based decisions, focused on assuring quality products.

The successful candidate will work with cross-functional teams ensure successful scale up to commercial scale manufacturing (successful First Lot To Stock [FLTS] process). Together with R&D, Technical Centers and Plant operations, the incumbent will assess critical-to-quality attributes and ensure compliance of new products to regulations and support successful manufacturability of new formulations and products. Reporting to the Senior Manager, Design Assurance, the Project Leader will ensure that all Abbott Nutrition products meet the highest standards for quality required by regulations.

WHAT YOU'LL DO
  • Assure that the design and testing for all Abbott Nutritional products are fully compliant with applicable regulations
  • Facilitate product technical risk management activities through product development stages via Failure Mode Effects Analysis (FMEA) and Root Cause Analysis (RCA)
  • Use Food Science knowledge to assure design, evaluate risk and successful manufacture
  • Monitor product, process and package quality performance and identify quality related issues and trends
  • Work with and provide direction across multiple functions including Supply Chain, R&D, Operations, and Regulatory
  • Prepares Quality documents and ensures accuracy of documents within Quality Systems
  • Work on problems of complex scope that can have significant business impact
  • Identify and gain agreement on design criteria, negotiate compromises, balance quality with other criteria across all functional areas
  • Display working knowledge of relationships between regulations, labeling, process and product and working knowledge of applicable product regulations and policies


Accountability / Scope/Budget:
  • This position reports to the Senior Manager, 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.


EDUCATION AND EXPERIENCE, YOU'LL BRING

Required:
  • Bachelor's Degree in Food Science, Chemical Engineering, Chemistry, Microbiology or other technical science or related discipline
  • 3 or more years of working experience in the food/nutritional industry and experience in the scale-up and commercialization of product innovations


Preferred:
  • Master's Degree
  • Proficient technical writing skills; able to effectively and concisely communicate issues
  • Working knowledge of:

    Relationships between regulations, labeling, process and product

    Applicable regulatory standards and requirements for infant formula and nutritional products

    Quality management systems and regulatory requirements

    FMEA and risk assessment tools
  • Able to:

    Effectively organize and communicate technical information

    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

    Work independently and/or function with minimal supervision

    Maintain a high degree of accuracy and analytical thinking


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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