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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 medical conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout the product development lifecycle. The role encompasses the establishment of quality assurance protocols, execution of risk evaluations, investigation of discrepancies, and collaboration with interdisciplinary teams.

Key Responsibilities:

  • Formulate and execute quality assurance protocols that align with regulatory standards.
  • Examine calibration, qualification, and maintenance documentation for adherence to compliance.
  • Perform risk evaluations and devise strategies to address quality challenges.
  • Investigate discrepancies and implement corrective measures.
  • Work alongside teams to address quality-related concerns.
  • Offer guidance and training on quality standards and regulatory mandates.
  • Remain informed about industry trends and best practices in Quality Assurance.

Requirements:

  • Bachelor's degree in Bioengineering or a related discipline.
  • A minimum of 3 years of experience in quality engineering within regulated industries.
  • In-depth knowledge of regulatory standards and quality benchmarks.
  • Familiarity with quality management systems such as ISO 13485.
  • Exceptional communication and interpersonal abilities.
  • Detail-oriented with robust organizational skills.

Working Conditions:

  • Office setting with occasional laboratory visits.
  • Flexible scheduling is necessary.
  • Some light lifting may be required.
  • Aseptic gowning capability is essential.

Celularity is an Equal Opportunity Employer.