Hybrid Senior QA Document Control Specialist

Personalis; Fremont (CA); Hybrid; USD 111,751,000 - 126,519,000; Full time

Job summary

The Sr. Document Control Specialist (Temp) at Personalis in Fremont leads daily document control within our Quality Assurance team, applying ISO 13485 and FDA 21 CFR Part 820 standards. This role manages DCOs, EDMS, and cross‑functional reviews with minimal supervision.

The ideal candidate has a Bachelor's degree, 3+ years in regulated document control, hands-on EDMS experience (CQ a plus), and strong technical writing and communication skills. Hybrid schedule: Mon & Tue in-office.

Qualifications

• Bachelor's degree or equivalent experience in document control.
• 3+ years of document control experience in regulated medical device, IVD, or pharma environments.
• Hands-on EDMS experience; CQ a plus.
• Solid working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.

Responsibilities

• Triage, review, re-format, proofread, and process DCOs through the EDMS to ensure clarity, consistency, and compliance with quality standards.
• Partner with cross-functional teams to resolve DCO discrepancies and expedite approvals.
• Maintain accessibility of Quality System documentation, master signature logs, data, and records inventory.
• Facilitate periodic document reviews, follow up on past-due items, and escalate issues as needed.
• Manage multiple document projects and provide QA support as assigned.

Skills

Attention to detail

Independence & prioritization

Communication & technical writing

Software proficiency

Education

Bachelor's degree

Tools

EDMS

ComplianceQuest (CQ)

Job description

The Sr. Document Control Specialist (Temp) at Personalis in Fremont leads daily document control within our Quality Assurance team, applying ISO 13485 and FDA 21 CFR Part 820 standards. This role manages DCOs, EDMS, and cross‑functional reviews with minimal supervision.

The ideal candidate has a Bachelor's degree, 3+ years in regulated document control, hands-on EDMS experience (CQ a plus), and strong technical writing and communication skills. Hybrid schedule: Mon & Tue in-office.