Senior Engineer Technical Writer
Job Summary
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
Complete Job Description
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