Sr. Quality Engineer

Sr. Quality Engineer

Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Navigate various government and industry regulations including ISO 9001. Develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Special Product and Process Validations, Test Method Validations (TMV), and Gage R&R (GRR). Coordinate Corrective & Preventive Actions (CAPA) using Track Wise or similar Quality Mgmt. Systems (QMS) software tools, Nonconformance, Change Control, Deviations, and Good Manufacturing Practices (GMP). Utilize various Enterprise Resource Planning (ERP) systems to include SAP manufacturing systems. Coordinate Failure Mode and Effects Analysis (FMEA), validation, methodical problem solving, product design & manufacturing engineering. Utilize Statistical Process Control (SPC) and Acceptance Sampling (AS). Utilize Minitab for data analysis and visualization. Must be able to work 2nd shift (2 pm to 10:30 pm). Relocation assistance not available for this position.

Master's degree or foreign equivalent in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field and two (2) years of experience as a quality engineer or related occupation. Must possess at least two (2) years of experience with each of the following: ISO 9001; TMV, GRR, and IQ/OQ/PQ; CAPA using Track Wise, and QMS software tools; Non-Conformance, Change Control, Deviations, and GMP; SAP; FMEA, validation, methodical problem solving, product design, and manufacturing engineering; SPC and AS; and Minitab.