Grand Rapids, MI30+ days ago
Must possess at least three (3) years' experience with each of the following: GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, and cause mapping; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; FTQ principles; and Cardiac surgery devices. Basic Qualifications: Requires a Bachelor's degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and five (5) years of experience as a Quality Engineer or related occupation in medical device industry; or Master's degree or foreign equivalent in Biomedical, Mechanical, Industrial Engineering or related engineering field and three (3) years of experience as a Quality Engineer or related occupation in medical device industry.