Job Description
Job Description
Roles and Responsibilities
- Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
- Work with site teams to implement QMS and Regulatory requirements for Modality NPI and IB programs.
- Resolves issues using established procedures and collaborate with site teams to drive Corrective and preventive actions.
Required Qualifications
- This role requires working experience in the Quality Management System in Healthcare Industry
Desired Characteristics
- Knowledge of ISO13485 and regulatory standards FDA 21 CFR, EU MDR applicable for medical device industry
- Work experience in Quality Management system including Design controls and SDLC domain.