As a project leader, you are part of new product introduction(NPA)team in quality management and quality assurance and your task includes:
- Design , control and CAPA(corrective and preventive actions) for medical devices, ISO13485.
- Define the product quality inspection process, the requirement of tooling, and competencies.
- Identify QA requirements based on failure mode analysis.
- Make improvements and CAPA with a primary focus on product.
- Propose and lead short and midterm improvement.
- Make report for process and product performance.