RA/QA Technical Writer

We are seeking an experienced RA/QA Technical Writer to support quality and regulatory documentation for a leading medical technology company. This role will play a critical part in ensuring compliance with FDA and ISO standards while supporting audits, risk management, and quality processes across the product lifecycle.

This is a hands-on, individual contributor role ideal for someone who can work independently and translate complex technical and quality requirements into clear, compliant documentation.

Key Responsibilities

• Develop, review, and maintain quality and regulatory documentation (SOPs, work instructions, validation protocols/reports, and audit materials)
• Ensure compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards
• Support internal and external audits, including documentation readiness and responses
• Assess risks and contribute to quality improvement initiatives (CAPA, change control, risk analysis)
• Collaborate cross-functionally with engineering, manufacturing, and quality teams
• Assist in coordinating and documenting quality training activities

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
• 3+ years of experience in medical device, pharmaceutical, or other regulated industry
• Strong background in quality systems and regulatory compliance (FDA, ISO 13485)
• Proven experience writing controlled documentation (SOPs, validation reports, CAPA, etc.)
• Experience supporting audits and regulatory inspections
• Ability to work independently with minimal supervision