Job Details. Required. Must have two to four (2-4) years of related work experience in the Medical field. Experience in Quality Engineering. Strong understanding in GMP and/or regulatory requirements, specifically 21 CFR 820, ISO 13485, and ISO 14971. Strong communication, collaboration, and problem-solving skills. Both, FDA, and ISO regulations knowledge. Strong root cause analysis skills. Preferred. Operations supplier quality experience. Exper...