Quality Engineer MTF

Musculoskeletal Transplant Foundation•Edison, NJ

About The Position

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities. Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles. The Quality Engineer supports the validations of a designated business unit, including the planning, writing and data analysis for validations. The QE uses technical writing skills, statistics and other tools to implement products and processes to support production and laboratories. Mon-Fri, 8:15AM-4:30PM

Requirements

Bachelor of Science in engineering or scientific field
3 years of validation experience in a regulated industry
Basic statistics (ANOVA, t-test)
Fluent in Microsoft Office, specifically Word and Excel
Strong verbal and written communication skills
Be able to lift 25 lbs infrequently, travel up to 20% of the time
Ability to gown in clean room environment

Nice To Haves

Bachelor’s Degree in Biomedical or Chemical Engineering; Master’s Degree in Engineering or Science
3-5 years of validation experience in a regulated industry
CQE
Working knowledge of statistics including the use of statistical software (Excel, MiniTab)
Working knowledge of cell biology, microbiology or other biological science

Responsibilities

Plan validation scope and requirements for product and process launches
Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated.
Perform data analysis that includes use of statistical tools, trending, capability analysis, sampling plans, ability to perform correlation analysis and other calculations as required.
Perform risk assessments independently and as a team applying techniques including Hazard Analysis per ISO 14971
Coordinate with internal and external personnel for standards, data, testing.
Perform other duties as assigned(exempt)(non-exempt)