Sr. Document Control Specialist (Temp - 3 Month) (Medtech)

Location: Fremont, California, United States; hybrid attendance required on Mondays and Tuesdays

Salary: $39.00–$44.00 per hour

Company

hirify.global develops personalized cancer testing products using tumor-and-normal genomic profiling, proprietary algorithms, and assays for minimal residual disease, recurrence detection, targeted therapy selection, and biomarker strategy.

What you will do

• Manage document change orders through the electronic document management system, including triage, review, reformatting, proofreading, and processing.
• Collaborate with change initiators and reviewers across departments to resolve discrepancies and expedite approval workflows.
• Control, file, and maintain Quality System documentation, master signature logs, data, and records inventories.
• Facilitate periodic document reviews, track overdue items, and escalate system issues or workflow bottlenecks.
• Manage multiple document projects and provide additional Quality Assurance support as assigned.

Requirements

• Bachelor’s degree or equivalent experience in document control.
• 3+ years of document control experience in a regulated medical device, IVD, or pharmaceutical environment.
• Hands-on experience with Electronic Document Management Systems.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Strong proofreading, formatting, prioritization, communication, and technical writing skills.
• Advanced proficiency with Microsoft Office, Adobe Acrobat, and Google Workspace.

Nice to have

• Experience with ComplianceQuest.

Culture & Benefits

• Temporary three-month position within the Quality Assurance team.
• Work in a regulated environment focused on personalized cancer testing and genomic insights.
• Reasonable accommodations are available for individuals with disabilities during the application, interview, and employment process.
• Equal opportunity employer committed to the full inclusion of all individuals.