Medical’s (KMI) processes and procedures to the FDA (US) and PMDA(Japan) Quality System Regulations, and ISO 13485. This role... overall suitability and effectiveness of KMI’s Quality System. Shall develop and implement strategies and supporting...
verification and validation, project engineering, and early manufacturing engineering, in accordance with the company’s Quality... that product documentation is in accordance with Quality System requirements. Project Management: Provide input and may coordinate...