Quality Engineer

The Quality Engineer will be responsible for executing and maintaining elements of the Quality Management System (QMS) to ensure full compliance with FDA 21 CFR 820 and ISO 13485 requirements.

Requirements

• Bachelor's Degree in engineering or related field
• Working knowledge and/or experience in a regulated industry
• FDA and medical device experience
• Knowledgeable of FDA/ISO applicable guidance, regulations, and standards, including ISO 13485
• Strong attention to detail and excellent organizational skills
• Able to work proactively and independently
• Able to multi-task and efficient in time management
• Excellent verbal and written communication skills
• Able to work in a team environment
• Proficient in Excel, Word, and other desktop/general business systems