Insight Global is looking for a Document Controls Specialists for a medical device client in the Irvine, CA area. The Document Controls Specialist will be responsible for managing the entire document lifecycle, including creation, revision, approval, and archival. This role ensures compliance through the use of electronic quality management systems (EQMS) such as ComplianceQuest and MasterControl. The specialist will oversee both internal and external documents, including industry standards like ISO and ASTM, and will proactively notify teams of new standards or test methods while procuring updated documents as needed. Additionally, the position requires maintaining proper revision control and ensuring the security of all controlled documents.
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Required Skills & Experience
Minimum 2 years in document control roles.
Proficiency in Adobe PDF Suite and Microsoft Office Suite.
Hands-on experience with Electronic Document Control Systems (EQMS).
Strong organizational skills and attention to detail.
Nice to Have Skills & Experience
Familiarity with regulatory standards and quality systems.
Ability to manage external standards and communicate updates effectively.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.
Document Control Specialist • Irvine, CA, United States