RA/QA Technical Writer – Medical Device (Contract)

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 ResponsibilitiesDevelop, 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 standardsSupport internal and external audits, including documentation readiness and responsesAssess risks and contribute to quality improvement initiatives (CAPA, change control, risk analysis)Collaborate cross-functionally with engineering, manufacturing, and quality teamsAssist in coordinating and documenting quality training activitiesQualificationsBachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)3+ years of experience in medical device, pharmaceutical, or other regulated industryStrong 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 inspectionsAbility to work independently with minimal supervision