Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance - Columbus, OH
$86,700–$173,300 year
On-siteColumbus, Ohio, United States
Job Summary
Senior Project Leader TPM Quality Assurance leads QA across multiple suppliers for co-pack nutritional products and pediatric accessories, focusing on CAPA event management, project management for new product launches and changes, and ensuring compliance with the Abbott quality system. Serves as a supplier representative across regulatory, R&D, procurement, packaging engineering, and internal stakeholders; acts as SME for Plant CAPA processes and liaison to Division Quality Systems for CAPA and AMR metrics. Collaborates with cross-functional teams to lead or support failure investigations, writes/reviews specifications and validation packages, and uses quality tools to improve product quality while maintaining current documentation and ensuring regulatory compliance. Location: Columbus, OH; standard work shift; travel up to 20%.
Required Qualifications
- Bachelor's degree, preferably in science, engineering or life/physical sciences
- Preferred experience within a Global, multi-cultural organization
- Preferred experience in Quality Assurance or supplier quality management: at least 5 years in a QA role / Compliance / Quality Systems
- Experience within a federally regulated industry is a plus
- Thorough knowledge of manufacturing processes and QA principles; ability to operate to internal and federal regulations
- Strong communication with suppliers and internal stakeholders; ability to manage multiple activities/projects with urgency
- Experience coordinating CAPA activities and MRB meetings
- Knowledge of FDA/Regulatory requirements and ISO standards
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