• Excellent technical writing, editing and proofreading skills.
• Advanced Microsoft Word skills, including styles, templates, tables, numbering and document formatting.
• Experience creating controlled documentation in a regulated industry and applying good documentation practices.
• Strong verbal communication, active listening, interviewing and clarification skills.
• Excellent attention to detail, accuracy and consistency.
• Strong planning, organization and time-management skills, with the ability to work independently.
• Ability to track and report documentation metrics.
• Self-motivated team player with strong interpersonal and cross-functional collaboration skills.

Preferred Experience

• Experience in the medical device, pharmaceutical or another highly regulated industry.
• Knowledge of ISO 13485 or comparable standards and regulated quality systems.
• Experience with validation documentation, electronic document or quality management systems including Windchill, and controlled change workflows.
• Experience contributing to formal, public or published reports.