Associate Quality Engineer

Mtf Biologics • Edison, NJ

278d

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. 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.

Requirements

• Bachelor's degree in scientific discipline (e.g. Biology, Chemistry, etc.)
• 0-3 years of quality assurance or FDA regulatory proficiency required.
• 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).

Nice To Haves

• Bachelor's degree in engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science, Tissue Engineering)
• Industry certification (i.e., ASQ-CQA, CQE; CTBS)

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 report results to Quality Engineering Management.
• Assist with writing Standard Operating Procedures, specifications, validation procedures and final reports.
• Assist 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.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree