Lead Medical Device QMS Technical Writer (Hybrid)

Downtown Boulder Partnership; Sunnyvale (CA); Hybrid; USD 171,924,480 - 186,251,520; Full time

Job summary

Two highly skilled QMS Technical Writers are sought to develop and maintain clear, compliant internal process documentation in a regulated environment. The role requires 3–5 years of experience, strong writing, editing, and grammar skills, and the ability to collaborate with cross‑functional teams and SMEs in a fast‑paced setting.

Responsibilities include leading documentation projects, ensuring GDP and QA guidelines compliance, and mentoring junior writers while adapting to new templates and

Qualifications

• 3–5 years of experience in a regulated environment.
• Develop and maintain compliant internal process documentation.
• Collaborate with cross-functional teams and SMEs.
• Familiarity with GDP, Quality and regulatory guidelines.

Responsibilities

• Write, edit, and maintain internal process documentation in line with standards.
• Provide writing support for templates and guidelines, developing flowcharts.
• Ensure compliance with GDP and document control requirements.
• Act as lead writer on projects, mentoring other writers and participating in regulatory training.
• Manage multiple deliverables under tight deadlines with cross‑functional teams.

Skills

Writing

Editing

Time management

Microsoft Word

Visio

Adobe Illustrator

Tools

Microsoft Word

Visio

Adobe Illustrator

Photoshop

Job description

Two highly skilled QMS Technical Writers are sought to develop and maintain clear, compliant internal process documentation in a regulated environment. The role requires 3–5 years of experience, strong writing, editing, and grammar skills, and the ability to collaborate with cross‑functional teams and SMEs in a fast‑paced setting.

Responsibilities include leading documentation projects, ensuring GDP and QA guidelines compliance, and mentoring junior writers while adapting to new templates and