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
December 27, 2022
BioTissue
Miami, Florida
FULL_TIME
JOB DESCRIPTION:
- 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).
- 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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