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Senior Engineer Technical Writer

Virtual Vocations Inc · New York, NY, USA · Remote ·

Job type:
Full Time

To support high-quality standards in medical device production, the full-time Senior Engineer Technical Writer will be responsible for writing Nonconformance Reports (NCRs), developing Quality Assurance methodologies, and driving continuous improvement initiatives while working in a hybrid remote environment.
Key responsibilities

Write complex NCRs, including investigations, product disposition, and closure actions
Collaborate with cross-functional teams to support root cause analysis and corrective actions
Identify and implement effective process control systems to meet internal and external quality requirements

Required qualifications

Bachelor's degree in engineering or science, or equivalent work experience
5-7 years of experience in Quality Management Systems (QMS)
Experience in the medical device manufacturing industry or similar
Advanced writing skills suitable for audit scrutiny
Knowledge of ISO 13485, 14971, and 21CFR Part 820