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
BioTissue
Miami, Florida
JOB DESCRIPTION:


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)


RESPONSIBILITIES:


  • 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.


EDUCATION AND EXPERIENCE:


Required


  • 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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