Responsible for leading development of and maintaining quality systems and providing quality system support for site and/or division.
Requirements:
Bachelor's or foreign equivalent degree in Biology, Biomedical Engineering (Eng), Industrial Eng or in related engineering or scientific field of study with minimum 2 years of professional experience in:
(1) Utilizing Statistical tools, including Minitab or related, and Six Sigma methodologies to analyze quality trends and identify, recommend, and implement quality process improvements;
(2) Assessing site Good Manufacturing (Mfg) Practice (GMP) and/or Good Lab Practice (GLP) processes and implementation to ensure compliance with federal medical device manufacturing requirements and related industry standards, including ISO 13485, ISO 14971 & FDA 21 CFR 820;
(3) Conducting inspection, verification and validation of components or materials used in GMP processes;
(4) Identifying and addressing recurring problems either with the quality of product or quality system;
(5) Documenting quality issues and performance measures for management review on monthly reporting basis.
Application Instructions:
Send resumes to: Abbott Laboratories, Elvia Salazar, 233 W. Wacker Dr. Floor 25, Dept. 32, Chicago, IL 60606. Refer to ad code: ABT-0102-ES.
Position is Full Time. An Equal Opportunity Employer. 40 hours/week.
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