Cleanrooms/ Environmentally Controlled Areas (ECA) and contamination control experience. The candidate must exhibit an above average knowledge of cleanroom/ ECA and contamination control concepts and requirements (i.e. ISO 14644 and ISO 14698).
Sterility Assurance testing (i.e. Bioburden testing, Sterility testing, Endotoxin testing, EO residual testing, etc) experience. The candidate must exhibit an average knowledge of Sterility Assurance testing concepts and requirements (i.e. ANSI/ AAMI/ ISO 11737, ANSI/AAMI ST72, ANSI/AAMI/ ISO 10993, etc.)
Knowledge of medical device regulations (i.e. 21 CFR Part 820 and ISO 13485).
Technical writing experience (i.e procedures, protocols, final reports, sterilization equivalency, etc).
The candidate must display excellent leadership, communication, and interpersonal skills. In addition, the candidate must be able to work on cross-functional teams, as well as independently (i.e. little to no supervision).
Ethylene oxide and/or gamma sterilization experience. The candidate must exhibit an average knowledge of ethylene oxide and/or gamma sterilization concepts and requirements (i.e. ISO 11135 and ISO 11137).
Steam/Reusable Instruments sterilization experience. The candidate should exhibit knowledge of the reusable instrument sterilization requirements.
Knowledge of packaging and product design issues as they relate to sterilization.
Knowledge of calibration requirements.
This position is accountable for supporting the terminal sterilization of medical devices globally. Failure to maintain accountability for MicroPort Orthopedics sterilization program may result in sever physical harm to a patient’s well-being, in addition to having severe financial and regulatory repercussion to MicroPort.
1-3 years of related experience
Bachelor’s Degree in Life Sciences, Engineering or a related discipline required