Job Description

Job Description

Job Description

Position: Senior Technical Writer

Overview:

We are seeking a Senior Technical Writer to collaborate with Quality Management System (QMS) process owners and subject matter experts to develop and refine top-level Standard Operating Procedures (SOPs). This role will ensure documentation aligns with regulatory requirements, business needs, and industry standards.

Responsibilities:

• Partner with subject matter experts across Quality Systems, Document Control, Regulatory, Design & Development, Supplier Quality, and Production Controls.
• Author new SOPs that incorporate regulatory requirements, standards, and business processes.
• Define and document key process inputs and outputs.
• Review and update existing SOPs to ensure compliance and accuracy.
• Contribute to documentation structure, design, and best practices.

Qualifications:

• Bachelor’s degree or equivalent experience.
• 5+ years of technical writing experience, with a focus on top-level procedures.
• 3+ years in medical device manufacturing.
• Strong organizational, communication, and English writing skills.
• Proficiency with Microsoft Office applications.
• Ability to work independently, manage multiple priorities, and meet tight deadlines.

Preferred Skills:

• Experience authoring and publishing controlled documentation.
• Familiarity with PLM systems (Arena preferred).
• Strong planning and multitasking skills.

Why Apply:

This is a great opportunity to play a critical role in shaping QMS documentation within a highly regulated industry. If you’re detail-oriented, collaborative, and passionate about creating clear, compliant processes, we encourage you to apply today.

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