Quality Engineer
Position Description:
Quality Engineer for Medtronic, Inc located in Tempe, AZ. Responsible for operations quality and compliance with respect to Hybrid and Integrated Circuit (IC) process validation, testing methods, procedures and requirement specifications. Maintain quality standards and protocol for processing materials into partially finished or finished materials product. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Navigate the complexities of working in a quality position in the biomedical/medical device industry. Navigate various government and industry regulations to include FDA Quality System Regulation 21 CRF 820 and ISO 9001, ISO 13485 and ISO 14971. Work to develop protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Product and Process Validations, and Test Method Validations (TMV). Coordinate Corrective & Preventive Actions (CAPA) using TrackWise, Nonconformance, Change Control, Deviations and Good Manufacturing Practices (GMP). Utilize various systems to include JDE, Factory Works or SAP manufacturing systems. Coordinate Failure Mode Effect Analysis (FMEA), validation, methodical problem solving, product design & manufacturing engineering. Utilize Design of Experiments (DOE), Statistical Process Control (SPC) and Acceptance Sampling. Utilize the Minitab or JMP for data analysis and visualization. Relocation assistance not available for this position. #LI-DNI.
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.
