Quality Engineer

Overview :

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 colleagues include :

a division of MTF Biologics, honors donors of non-transplantable organs and tissue by providing their gifts to the medical research community to combat and cure disease.

a division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospital and patients that they serve.

our sister organization, further expands our global reach to patients around the world

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.

Responsibilities :

Plan validation scope 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, ability to perform correlation analysis and other calculations as required.

Perform risk assessments independently and as a team applying techniques including FMEA and ALARP.

Coordinate with internal and external personnel for standards, data, testing.

Perform other duties as assigned(exempt)(non-exempt)

Qualifications :

MINIMUM JOB REQUIREMENTS

Education :

Bachelor of Science in engineering or scientific field

Experience :

3 years of validation experience in a regulated industry

Specific Licenses and / or Certifications :

Specialized Knowledge, Skill, and Abilities* :

Basic statistics (ANOVA, t-test), Fluent in Microsoft Office, specifically Word and Excel, Strong verbal and written communication skills

Work Environment :

Office Environment, Laboratory Environment and Occasional Clean Room Access

Physical Demands : if applicable)

if applicable)

Be able to lift 25 lbs infrequently, travel up to 20% of the time

Ability to gown in clean room environment

PREFERRED QUALIFICATIONS

Education :

Bachelor’s Degree in Biomedical or Chemical Engineering; Master’s Degree in Engineering or Science

Experience :

3-5 years of validation experience in a regulated industry

Specific Licenses and / or Certifications :

Specialized Knowledge, Skill, and Abilities :

Working knowledge of statistics including the use of statistical software (Excel, MiniTab)

Working knowledge of cell biology, microbiology or other biological science

INDMTF