Job Summary
A healthcare technology company is filling a position for a Remote Technical Risk Management Quality Engineer.
Individual must be able to fulfill the following responsibilities:
- Facilitate the creation of both top-down and bottom-up risk management tools
- Conduct analysis of existing similar products from the company and competitor products
- Ensure the systematic and logical conversion of customer requirements to product specifications
Applicants must meet the following qualifications:
- Bachelor of Science in Engineering or a related field
- Extensive hands-on experience with the ISO 14971 standard
- Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards
- Strong understanding of risk management requirements, tools, methodologies, and processes
- Experience working within a Quality Management System
- 4+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry
