Technical Writer

One of our large Medical Device companies is seeking an experienced Technical Writer to support key validation and quality initiatives for a large project of theirs. This role will play a critical part in drafting and maintaining validation and quality documentation to support regulatory and operational readiness.

Own the end-to-end drafting of validation and quality documentation, including but not limited to:

• Validation protocols and reports (IQ, OQ, PQ)
• Supporting quality and operational documentation
• Draft new validation procedures required for project activities under guidance from internal subject matter experts
  -Revise and update existing procedures to support this projects readiness across functional areas, including:
  Operations Quality Control (QC) Laboratory Product Release
• Ensure all documentation aligns with quality management system (QMS) requirements and validation standards
• Collaborate with cross-functional stakeholders and global partners to gather inputs and incorporate feedback efficiently
• Maintain document accuracy, consistency, and compliance with internal standards

• 2–4 years of experience in technical writing supporting validation activities or quality management systems
• At least 2 years of validation documentation (IQ/OQ/PQ)
• At least 1 year of regulated manufacturing or laboratory environments
  
  Strong understanding of validation principles
• Excellent written communication skills with a high level of attention to detail
• Ability to manage multiple document workflows and deadlines simultaneously