Technical Writer
Insight Global
Job Description
We are seeking an experienced Technical Writer with Quality Management System (QMS) expertise to support the harmonization of quality documentation across multiple acquired organizations within a medical device environment. This individual will be responsible for developing, revising, and standardizing quality procedures, work instructions, and process documentation to align with global quality standards and business objectives.
The ideal candidate will have a strong background in medical device Quality Systems, experience supporting QMS integration and harmonization efforts, and familiarity with Manufacturing Design Transfer activities. This role will partner closely with Quality, Regulatory, Engineering, and Manufacturing teams to ensure documentation is compliant, clear, and aligned across multiple sites and processes.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Skills and Requirements
• Bachelor's degree in Engineering, Life Sciences, Technical Communication, Quality, or related field.
• 5+ years of technical writing experience within a regulated industry.
• 3+ years of experience supporting Medical Device Quality Management Systems.
• Experience authoring and maintaining QMS procedures and controlled documentation.
• Experience participating in QMS integration, remediation, or harmonization initiatives.
• Strong understanding of:
o Design Controls
o Quality Systems
o Risk Management
o Validation requirements
o Manufacturing quality processes
• Ability to work cross-functionally with Quality, Manufacturing, Engineering, and Regulatory stakeholders.
• Excellent technical writing, editing, and document control skills.
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