Regulatory Compliance Engineer
hace 19 horas
In compliance with FDA, European MDD/MDR, and other international regulations, the Quality Systems Engineer I will perform work under supervision. This role requires frequent use and general knowledge of industry practices, techniques, and standards. You will assist with audit activities, participate in quality system activities, and compile quality metrics for trending purposes.
Main Responsibilities:
- Support internal and external audits.
- Compile periodic reports in a timely manner.
- Maintain records per procedure requirements.
Requirements
A Bachelor's degree in related engineering is required. Between 0-1 years' experience in the medical devices industry is preferred. English proficiency (B2 level as a minimum) and basic knowledge of cGMP, FDA 820 QSR, and ISO 13485 or other Quality Systems are essential. Experience in the medical device industry, FDA/ISO audits, NCR, and CAPA experience is a plus.
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