RAQA Technical Writer

Position Summary

The RAQA Technical Writer will be responsible for developing, standardizing, and maintaining clear and accurate documentation including operating procedures, work instructions, and forms. This role ensures that all documentation complies with internal standards, regulatory requirements, and best practices for clarity, consistency, and usability. The Technical Writer will collaborate closely with subject matter experts (SMEs), process owners, and cross-functional teams to capture complex processes and translate them into user-friendly documentation.

Key Responsibilities

• Develop, write, edit, and maintain operating procedures, work instructions, and forms in alignment with company policies, industry standards, and regulatory requirements.


• Partner with subject matter experts (SMEs) and process owners to gather information and ensure accuracy of technical content.


• Standardize documentation format and ensure consistency across departments.


• Review, update, and manage document revisions to reflect process improvements or regulatory changes.


• Ensure documentation complies with applicable quality management system (QMS) requirements (e.g., ISO 9001, ISO 13485, FDA, or other relevant standards).


• Create documentation that is clear, concise, and easily understood by intended users, including technical and non-technical audiences.


• Support audits and inspections by providing controlled, accurate documentation.


• Collaborate with training teams to align documentation with employee training and onboarding programs.


• Maintain document control within approved systems and ensure proper version management.


• Develop process flows that clearly illustrate the end-to-end solution.

Qualifications

• Bachelor's degree in Engineering, Technical Communication, English, Engineering, Life Sciences, or a related field, or equivalent experience.


• 3+ years of experience in technical writing, preferably within regulated industries (e.g., medical devices, pharmaceuticals, manufacturing).


• Strong knowledge of operating procedures, work instructions, and controlled forms.


• Familiarity with Quality Management Systems (ISO 9001, ISO 13485) and regulatory requirements preferred.


• Excellent written and verbal communication skills with a strong attention to detail.


• Ability to translate complex technical concepts into clear, concise documentation.


• Proficiency in Microsoft Office Suite and document management systems (e.g., SharePoint, MasterControl, or similar).


• Strong organizational and project management skills, with the ability to manage multiple priorities.

Desired Competencies

• Strong collaboration skills with cross-functional teams.


• Analytical thinker with ability to identify gaps and improve documentation processes.


• Commitment to accuracy, quality, and compliance.


• Adaptability in a dynamic, fast-paced environment.


• Proactively takes initiative to support and drive project activities.


• Ability to work independently with minimal guidance.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.