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Karen Salguero
Compliance Auditor @Abbott
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WORK HISTORY
Compliance Auditor @Abbott
US
Corporate Auditor
EDUCATION
ITCR
Licentiate degree, Industrial Engineering
SKILLS
ABOUT KAREN SALGUERO
I started as a Manufacturing Engineer and then as Quality Engineer supporting production lines in the medical industry. I have been conducting my quality career towards risk management (FMEAs), managing customer complaints and evaluating the product situation in the market, solving post-manufacturing issues and also being SME during audits. I have been trained at a general clinical level to understand the coronary anatomy, structure and functioning for linking this on how the products interact with patient and with other tools, this has allowed me to analyze the complaints in an integral way to be able to solve investigations (CAPAs) and propose / implement actions Corrective measures. I developed training to share this knowledge with other engineers and, more generally, with operators, so that they understand how their daily tasks affect the final use of the product in the patient.I\'ve been leader of technicians and engineers group, focused not only on the \"what\" but in the \"how\" to ensure excellence in the complaint investigation process and product performance monitoring and trending.Experienced quality engineer enrolled as an integral resource to align the customer voice (complaints) and regulatory compliance to obtain expected manufacturing outputs- Site representative for EU MDR remediation submission for products manufactured on-site. Key-point for topic training on-site
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