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.