position located in Memphis, TN. Job Duties: Completes Design History File documentation. Design of Experiments (DOE) and Statistical Process Control (SPC). Determines manufacturing operation requirements and process parameters. Develops plans to evaluate process repeatability and stability. Participates in procedure writing and review. Performs process and equipment validations. Provides technical support to other engineers. Reviews product performance data to identify trends. Supports manufacturing, development, and implementation processes. Utilizes FMEA within process development. Ensures compliance with GMP’s. Generates documentation for engineering protocols and reports. Implements quality system improvements. Writes engineering and manufacturing specifications. This candidate will participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product. Understand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gaging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC. Requirements: Certifications/ Engineering: Design Controls, DHF, and Engineering Documentation. QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance Education Level: Undergraduate Degree Industry Experience: 1 - 3 Years Desired Qualifications: Education Level: Technical Certification Graduate Degree Quality or Reliability Certification Industry Experience: 3 - 5 Years Project Management : Project Coordination Project Recordkeeping and Documents Six Sigma/Lean Sigma Certifications: Green Belt Black Belt