Associate 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 goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

To assist projects by establishing and maintaining the validation program in compliance with applicable government regulations and the standards of the American Association of Tissue Banks, the U.S. Food and Drug Administration, and other regulatory bodies.

Monday-Friday, 8:15AM-4:30PM

Responsibilities

• Assist with the definition and execution of process validations and equipment qualifications.
• Assist Quality Assurance, Research & Development, Process Engineering, and Regulatory with the implementation of quality system requirements and regulatory requirements as they relate to validation activities.
• Participate in interdepartmental teams to develop specifications, risk assessments, procedural and regulatory compliance (cGMP, QSR, GTP, and AATB Standards, as applicable) of tissue forms and medical devices.
• Coordinate special project testing with outside consultants and / or outside laboratories as needed. Perform analysis of data and reports results to Quality Engineering Management.
• Assist with writing Standard Operating Procedures, specifications, validation procedures and final reports. Assists in the identification and development of production controls for new products. Assist in writing risk assessment documents.
• Assist in quality engineering projects and perform additional duties as assigned.(exempt) (non-exempt)
  
  

Qualifications

MINIMUM JOB REQUIREMENTS

Education:

Bachelor’s degree in scientific discipline (e.g. Biology, Chemistry, etc.)

Experience:

0-3 years of quality assurance or FDA regulatory proficiency required

Specific Licenses and/or Certifications:

Specialized Knowledge, Skill, and Abilities*:

• Familiar with statistical concepts used for process capability analysis and sample size determination.
• Excellent communication, organizational, and technical writing skills.
• Must be computer literate, including Microsoft Office and statistical software (Minitab).
  
  

Work Environment:

Office Environment

Clean Room Access

Physical Demands:

( if applicable)

Compatible with working in a laboratory environment involving exposure to human tissue, chemicals, analytical and mechanical testing equipment.

Travel 10-15%

Preferred Qualifications

Education:

Bachelor’s degree in engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science, Tissue Engineering)

Experience:

Specific Licenses and/or Certifications:

industry certification(i.e., ASQ-CQA, CQE; CTBS)

Specialized Knowledge, Skill, and Abilities:

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)