About This Role
This assistant manager role involves overseeing the design and development stages of products, ensuring all processes are completed according to specifications and regulatory requirements. It suits an individual with a strong background in product engineering and quality assurance.
Responsibilities
- Overview the design and development stages to ensure performance and completion
- Provide product specifications during the development phase
- Receive notifications for customer change requests
- Prepare documents for MDR/MDD
- Review and approve test protocols and reports
- Review and approve the initiation and maintenance of Product Engineering Change Orders related to procedural changes
- Review and approve the implementation of the risk management program throughout the development process
- Review and approve the settings for parts, WIP, and product codes
- Review and approve the establishment, modification, updating, and maintenance of Product Standard Charts
- Review and approve the establishment and maintenance of Bills of Materials (BOM) and Bills of Operations (BOO)
- Review and approve the creation, modification, updating, and maintenance of technical files
- Review and approve the maintenance and control of label printing templates and artwork
- Review and approve the evaluation and maintenance of the EC Declaration of Conformity
- Review and approve design verification processes
- Review and approve the collection of design transfer requirements for development and the establishment of the Input/Output (IO) table
- Review and approve the revision and updating of the IO table throughout the development cycle
- Review and approve the conduct of literature research, appraisal, and analysis of relevant data
- Review and approve the evaluation and updating of clinical data
- Perform other responsibilities assigned by a superior
Requirements
- Knowledge in planning, testing, evaluation, and reporting
