This is an excellent opportunity to work as a

Quality Engineer

for a global engineering and manufacturing company in Memphis, Tennessee. This is an exciting position with full benefits and we are looking to interview and hire as soon as possible.

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

QUALIFICATIONS:

• 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 gagging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
• Design Controls, DHF, and Engineering Documentation
• QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance

EDUCATION:

·          High School Diploma or Equivalent

·          Undergraduate Degree

For immediate assistance, please send resume to Mila.Crain@talagy.com .