Quality Engineer MTF

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 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

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)

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)

• 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:

CQE

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

 

 

 

 

 

Benefits Information

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental,  Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
• Sword Health (at home Physical Therapy)