QA Compliance Manager
Highly accomplished QA Compliance Manager with extensive experience in the medical device industry, specializing in complaint management, CAPA, and post-market surveillance. Proven leader adept at streamlining processes, ensuring regulatory compliance (cGMP, FDA), and driving quality improvements. Expertise includes managing complex investigations, developing quality metrics, and serving as a subj...
Experience: 21+ years
Elizabeth Delgado provides regulatory consulting services to clients in:
Holds an Associate's Degree in Business Software Applications from Heald College, providing a foundational understanding of business operations and software systems relevant to the medical device industry. This educational background complements their practical experience in quality assurance and regulatory compliance.
Boasts extensive experience in the medical device industry, progressing to a QA Compliance Manager role and demonstrating a strong track record in post-market surveillance and complaint management. Proven ability to manage complex complaint processes, CAPA investigations, and regulatory reporting across reputable organizations such as Gynesonics, ZOLL Medical, Cepheid, Intuitive Surgical, and Boston Scientific. Expertise includes streamlining post-market surveillance operations, ensuring cGMP compliance, and serving as a key subject matter expert during regulatory inspections.
Highly accomplished QA Compliance Manager with extensive experience in the medical device industry, specializing in complaint management, CAPA, and post-market surveillance. Proven leader adept at streamlining processes, ensuring regulatory compliance (cGMP, FDA), and driving quality improvements. E...
With 21 years of experience in the medical device industry, this consultant specializes in complaint management, CAPA, and post-market surveillance, showcasing their regulatory expertise depth. They have extensive FDA and regulatory body experience, having worked with organizations like Gynesonics, ZOLL Medical, and Boston Scientific. Their technical competencies in SAP, Trackwise, Salesforce, and CMS, combined with their Six Sigma Green Belt certification, demonstrate their ability to drive quality improvements. This consultant's background in managing complex investigations, developing quality metrics, and ensuring cGMP compliance makes them uniquely valuable for medtech companies seeking regulatory expertise and quality assurance support.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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