QTS is currently seeking a full-time Sterilization Specialist to lead technical support for the planning and executing of process qualifications and validations related to product sterilization and cleaning. An ideal candidate will enjoy working in a technical, collaborative environment and will have strong organization and prioritization skills.
Provide engineering support for the Sterilization and Cleaning Validation process and documentation. Includes:
Research and development of initial sterilization validation plan for new devices and
Prepare validation or performance qualification protocols for new or modified manufacturing processes.
Write validation and other study reports
Oversee routine audit and re-validation of existing
Provides price estimates and/or quotations for engineering validation work to
Resource for development and maintenance of environmental monitoring procedures, qualification, and validation.
Complete investigation and resolution of sterilization or cleaning related issues and anomalies.
Other duties as assigned.
Skills and Experience
BA in a technical field, with an emphasis in Biology, Microbiology, or Chemistry
Minimum of 3-5 years of experience in a related field.
Microbiology as applicable to medical device sterilization.
Familiarity with applicable AAMI, ASTM and ISO standards related to medical device sterilization, cleaning.
Technical writing for a variety of internal and external clients.
Familiar with cleanroom manufacturing practices and standards.
About Quality Tech Services, LLC
Quality Tech Services, LLC. is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. QTS offers a technical service to assist medical device OEMs throughout the nation with cleanroom assembly and packaging operations. As an employee at QTS, you’ll enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service.