MedTech Technical Writer: GMP & Regulated Docs

Edwards Lifesciences Gruppe; United States; On-site; USD 68,000 - 96,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Technical Writer to own controlled documentation ensuring GMP traceability and audit readiness. You will produce design control artifacts and user-facing docs, partnering with engineering, quality, and product teams in a regulated environment.

The role requires a Bachelor’s degree in a related field and 3+ years of technical writing experience, onsite near Irvine with no relocation assistance.

Qualifications

• Bachelor’s degree in a related field; 3+ years of technical writing experience preferred.
• On-site role based in Irvine, CA; relocation not provided.

Responsibilities

• Create and maintain GMP-aligned documentation and controlled records.
• Produce and maintain design control artifacts and user-facing documents.
• Coordinate with engineering, quality, and product teams to capture changes.
• Edit, review, and ensure clarity, grammar, punctuation, and usability of documents.
• Collaborate with cross-functional teams and respond to clarification requests.

Skills

Editing

Proofreading

Technical writing

Education

Bachelor's degree in a related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Publisher

Adobe Photoshop

Job description

Edwards Lifesciences in Irvine, CA seeks a Technical Writer to own controlled documentation ensuring GMP traceability and audit readiness. You will produce design control artifacts and user-facing docs, partnering with engineering, quality, and product teams in a regulated environment.

The role requires a Bachelor’s degree in a related field and 3+ years of technical writing experience, onsite near Irvine with no relocation assistance.