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Quality Assurance Engineer

2 months ago

Florham Park, New Jersey, United States Celularity Full time
Quality Engineer at Celularity Inc.

Celularity Inc. is a pioneering biotechnology firm dedicated to advancing placental-derived cell therapies aimed at treating a variety of health conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout product development. The role encompasses the establishment of quality assurance protocols, execution of risk evaluations, examination of non-conformances, and collaboration with interdisciplinary teams. The ideal candidate should possess a Bachelor's degree in Bioengineering or a related discipline, alongside a minimum of 3 years of experience in quality engineering within regulated industries. A robust understanding of regulatory standards and quality benchmarks is essential.

Key Responsibilities:

  • Formulate and execute quality assurance protocols adhering to regulatory standards.
  • Assess calibration, qualification, and maintenance documentation for adherence.
  • Perform risk evaluations and devise strategies to address quality challenges.
  • Examine non-conformances and implement corrective measures.
  • Work in conjunction with teams to resolve quality-related challenges.
  • Offer guidance and training on quality benchmarks and regulatory mandates.
  • Remain informed about industry trends and best practices in Quality Assurance.

Requirements:

  • Bachelor's degree in Bioengineering or a related field.
  • At least 3 years of experience in quality engineering within regulated industries.
  • Comprehensive knowledge of regulatory standards and quality benchmarks.
  • Familiarity with quality management systems such as ISO 13485.
  • Outstanding communication and interpersonal abilities.
  • Detail-oriented with excellent organizational capabilities.

Working Conditions:

  • Office setting with occasional laboratory visits.
  • Flexible scheduling is necessary.
  • Some light lifting may be required.
  • Aseptically gowning is a requirement.

Celularity is an Equal Opportunity Employer.