Senior Development Quality Engineer

BioTissue Miami, Florida
senior engineer technical design engineering r&d process development technical operations operations engineer quality system regulatory cross functional
January 26, 2023
Miami, Florida

The experienced Senior Development Quality Engineer will ensure the new product development and product improvement activities related to its HCT/Ps and Medical Devices are performed in accordance with applicable Quality System and regulatory requirements. The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to product and process development teams in R&D, Technical Operations and Quality. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

(Strong preference for individuals with experience in Human cells, tissues, or cellular or tissue-based products (HCT/P s)


  • Lead Risk Management activities from product & process concept through commercialization and support the maintenance of associated risk files
  • Lead and/or support on-time completion of Control Strategy deliverables
  • Support the establishment of objective, measurable, and verifiable product requirements
  • Support manufacturing process development & qualification for new product and design changes
  • Support technology transfer between R&D and Technical Operations
  • Support product and process improvement initiatives, including any cross-functional investigation and resolution activities
  • Support the establishment of component specification definitions, supplied component sampling plan development & AQL, and vendor qualifications
  • Support biocompatibility, comparability, and sterilization qualifications.
  • Support audits and quality system improvement activities
  • Comply with the Company, U.S. FDA, and other standards and requirements, as applicable.



  • Bachelor s degree or higher in a Engineering or Technical Field in life sciences
  • Strong knowledge of FDA regulations such as 21 CFR parts 11, 210/211, 600, 820, and 1271.
  • Experience applying ISO 13485 and ISO 14971
  • Minimum of 10 years of experience biotech and/or HCT/P-based product and process development, either in R&D, Process/Manufacturing Engineering, Technical Operations, and/or Quality Engineering
  • Experience in supporting Control Strategy design, and strong understanding of QTPP, CQA, CPP, and key attributes & parameter definition
  • Experience in developing risk assessments, FMEA, and other risk documents
  • Experience in technical writing to support regulatory filings (for example, IND and BLA).

Highly Preferred

  • Advanced Degree in Biomedical Engineering or related discipline
  • Experience in biologics and biotech, with emphasis on HCT/P product and process design
  • Working knowledge of statistics and its application to SPC

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