Quality Engineer
Basic Qualifications:
Masters’ Degree or foreign equivalent in Mechanical, Industrial, or Biomedical Engineering or related engineering field and one (1) year of experience as a quality or manufacturing engineer or related occupation within biomedical or medical device industry Must possess at least one (1) year of experience with each of the following: FDA QSR 21 CRF 820, ISO 9001, ISO 13485, and ISO 14971; Developing protocols for IQ/OQ/PQ; Special Product and Process Validations and TMV; CAPA using TrackWise, Nonconformance, Change control, Deviations, and GMP; JDE, Factory Works, or SAP manufacturing systems (1 year of any); FMEA, validation, methodical problem solving, product design & manufacturing engineering; DOE, SPC, and Acceptance Sampling; Minitab or JMP.