Quality & Regulatory Engineer
Benefits:
competitive salary
medical benefits
opportunity to work on the most innovative technology
Education Requirements:
Bachelor’s degree in Engineering or a related field
Advanced degree preferred
Experience Requirements:
Technical knowledge and applicability of FDA regulations and ISO standards
Prior experience with medical imaging devices
Other Requirements:
Creative and resourceful
Excellent writing and presentation skills
Excellent planning & organizational skills
Exhibit quality of leadership
Skilled in data analysis and reporting
Responsibilities:
Create and manage a quality management system (QMS)
Document, review, and maintain quality records
Perform periodic internal quality audits and analyze quality metrics to suggest improvements
Initiate necessary actions when anomalies are identified
Be the lead during external audits
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