Maritza Castillo
Quality Assurance Manager at Apnea Sciences Corporation- Claim this Profile
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Bio
Credentials
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Lead QMS Auditor
Oriel STAT A MATRIXSep, 2019- Sep, 2024 -
Medical Assistant
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Experience
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Apnea Sciences Corporation
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Assurance Manager
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Oct 2018 - Present
-Evaluates the Quality Management Systems to ensure compliance to current regulations-Work with various departments to ensure changes are completed in a timely manner -Manages device listings and submissions in various countries-Review all labeling/marketing materials associated with products and initiate any changes based on regulatory requirements or usability feedback -Knowledgeable of ISO 13485 & FDA 21 CFR.820 (Medical Device Regulatory Standard) -Conducting Internal Auditing-Organize, submit, and execute clinical Institutional Review Board studies to evaluate the usability of a medical device among consumers-Ensure Quality Objective are reached annually-Acted as a main point of contact for FDA and regulatory bodies during applications and audits.
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Electronic Data Interchange Specialist
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Jun 2018 - Present
-Receiving vendor purchase request -Facilitate the logistics of incoming purchase orders-Coordinating with shipping department-Verifying deliveries-Invoicing
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Document Control Manager
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Mar 2015 - Present
-Maintaining and controlling documents pertaining to the Quality Management System (QMS) -Ensure documents are correspondence under ISO & FDA medical regulatory standards -Conduct weekly meetings with the team pertaining to each department duties -Review and approve all labeling/marketing materials associated with products and initiate any changes based on regulatory requirements or usability feedback -Maintain and update QMS to ensure forms and dates are effective and valid within a timely manner
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Customer Account Representative
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Mar 2015 - Present
-Provided product support to the end users and medical professionals. -Maintained the customer complaint process including Medical Device Reporting (MDR) to the FDA.-Tracked and reported customer feedback which resulted in organizational process improvements that increased productivity.
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Laguna Behavioral
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United States
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Medical Practices
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1 - 100 Employee
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Receptionist/Medical Billing
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Apr 2014 - Mar 2015
-Provided assistance to Medical Professional including but not limited to; Appointment Scheduling, meeting setup, rescheduling -Medical Billing -Provided assistance to Medical Professional including but not limited to; Appointment Scheduling, meeting setup, rescheduling -Medical Billing
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