In this role, the selected candidate must be an individual with extensive knowledge of medical device quality system regulations (i.e. FDAs Quality System Regulation and ISO 13485) and the ability to develop, implement and maintain a quality system compliant with these requirements.
In this role, you will interact with operators on a regular basis to ensure effective communication of production and compliance related changes in procedures and process changes. Conduct formalized training for operative/technical personnel as necessary.
In this role, the selected candidate will drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing successful implementation into production.
The candidate will work with disciplinary team to define top-level system requirements, build analytical models to test various control strategies, and prototype and test solutions on hardware and hardware-in-the-loop test platforms.
In this role, you will be responsible for developing technical specifications, development of project design basis, providing direction and guidance to drafters and designers, directing the flow of drafting and designer duties, insuring design schedules are met, including regularly providing project status updates to project engineer.
In this role, you will create test plans, write test cases and organize them in a test management tool. The selected candidate will create automated tests and systems within an overall continuous integration environment.
The successful incumbent will develop, troubleshoot and optimize our fiber production processes. They will identify opportunities to improve cost, quality, yield and productivity and then lead them to fruition. They will lead projects, develop new manufacturing techniques, and interface with R&D in coordinating the release of new products.