Paul Trujillo, Regulatory & Quality Assurance 

Paul has more than 25 years of supervisory and managerial experience working with medical device companies, primarily dealing with product related processes, quality system and compliance issues related to FDA and international requirements and regulations.

 

His industry specialization includes 28 years working primarily with IVD’s and medical devices, with an emphasis on problem solving, resolution of compliance and enforcement issues, as well as conducting internal and external audits to assure conformance with established guidance and regulatory requirements, both domestically and internationally. An accomplished auditor and quality assurance expert, Paul boasts extensive international experience with compliance to ISO standards in assessing medical devices and quality control systems. During his long and distinguished career in the field, Paul has handled all phases of regulatory and quality assurance compliance for both start-ups and leading medical device manufacturers, where he has been responsible for implementing best practices for SPC, CAPA, Risk Analysis, Environmental control for manufacturing and full Quality Systems.

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