QA Manager, document Control

I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complaint activity for management review, preparation of annual product reviews, working with cross functional teams on CAPA activities and resolution, leading validation activities, and managing document control activities. I have experience with MedWatch reporting to the FDA, customer responses for complaint investigations, 510K submission preparations, and regulatory and internal audits. I am knowledgeable in FDA 21 CFR and EU regulations with experience in ICH requirements.

Aircraft Rigging Assembler

Charles Town, WV