- Fresenius Medical Center (Waltham, MA)
- …devices (eg, ISO 13485, ICH Q7/Q10, ISO 14971, ISO 10993, IE 62366, GxP ) required + In-depth knowledge in the interpretation of FDA guidelines, Good Manufacturing ... Practices (GMP) and relevant quality standards for pharmaceuticals and medical devices + Expertise in reviewing, revising, and writing Standard Operating Procedures (recent auditing expertise preferred) + Demonstrated expertise in specialized processes related… more