What are the responsibilities and job description for the RA/QA Technical Writer – Medical Device (Contract) position at Comrise?
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
Salary : $62 - $67