Product Recall Specialist

1 week ago


Alameda, California, United States Abbott Laboratories Full time
About the Role

We are seeking a highly skilled Product Recall Specialist to join our team at Abbott Laboratories. As a key member of our Diabetes Care division, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Initiate and execute Field Action related activities, serving as a key contact for internal and external customers.
  • Implement and execute the Field Action process through completion, ensuring timely submission to regulatory authorities.
  • Manage and track responses to regulatory agencies, ensuring compliance with business standards.
  • Compile and review Field Action documentation packages, ensuring accuracy and completeness.
  • Act as a subject matter expert for business audits, providing guidance and support as needed.
Requirements
  • Bachelor's Degree or equivalent combination of education and work experience.
  • Minimum of 7 years of experience in a Quality function, with comprehensive knowledge of executing Field Action documentation and notifications.
  • Previous experience in completing Field Action packages and cross-functional experience.
  • Sound decision-making skills, contributing to high levels of competence, confidence, and credibility.
Preferred Qualifications
  • Masters Degree.
  • Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDR.
  • Strong and well-developed interpersonal communication skills.
  • Experience dealing with international locations and businesses.
About Abbott Laboratories

Abbott Laboratories 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.



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