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Quality Management Engineer
A company is looking for a Quality Management Engineer - Design Controls. Key Responsibilities Ensure product line's adherence with relevant regulations, standards, and quality management system processes Develop and manage quality plans, conduct milestone reviews, and support product risk analysis Drive process improvements and promote a culture of quality and safety within the product line Required Qualifications High School Diploma/GED (or higher) 5+ years of experience in Software as Medical Device (SaMD) 3+ years of experience with FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and IEC 62304 Preferred Bachelor's Degree in Engineering, Computer Science, Information Technology, or Biomedical Sciences Demonstrated experience with EU MDR and ISO 14971
A company is looking for a Quality Management Engineer - Design Controls.
Key Responsibilities
Ensure product line's adherence with relevant regulations, standards, and quality management system processes
Develop and manage quality plans, conduct milestone reviews, and support product risk analysis
Drive process improvements and promote a culture of quality and safety within the product line
Required Qualifications
High School Diploma/GED (or higher)
5+ years of experience in Software as Medical Device (SaMD)
3+ years of experience with FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and IEC 62304
Preferred Bachelor's Degree in Engineering, Computer Science, Information Technology, or Biomedical Sciences
Demonstrated experience with EU MDR and ISO 14971