Engineer I, Quality

Support the development and manufacture of medical devices. Work with Manufacturing and R&D to resolve product quality issues. Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties:Support R&D and Quality Engineers with design validation and design validation testing of new products. Support R&D and Quality Engineers in preparing quality specifications and receiving specifications. Coordinate and assist with first article inspections. Coordinate and support biocompatibility testing. Manage X-level documentation. Conduct test method validations. Coordinate implementation of new equipment by preparing equipment specifications and participating in installation qualifications and operational qualifications. Support the manufacturing of new products. Support various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis. Perform additional duties and responsibilities as assigned.