Quality Systems Engineer

3 days ago


Florham Park, New Jersey, United States Celularity Full time

We are seeking an experienced Quality Systems Engineer to join our Celularity team. The estimated salary for this position is $90,000 - $120,000 per year.

This role involves developing and implementing quality assurance processes and procedures in compliance with FDA regulations. As a Quality Systems Engineer, you will ensure that our product development and manufacturing processes meet the highest standards of quality.

The ideal candidate will have a strong background in quality assurance within FDA-regulated environments, particularly in biotechnology or pharmaceutical industries. This role requires a Bachelor's degree in Bioengineering, Biology, or related field, and minimum 3 years of experience as a Quality Engineer or in a similar role.

Responsibilities:

  • Develop and implement quality assurance processes and procedures.
  • Review calibration, qualification, and maintenance documents for compliance with regulations.
  • Collaborate with cross-functional teams to resolve quality-related issues.

Requirements:

  • Bachelor's degree in Bioengineering, Biology, or related field.
  • Minimum 3 years of experience as a Quality Engineer or in a similar role.
  • Experience with quality management systems such as ISO 13485 and 21 CFR Part 820.


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