Manage and maintain compliance with the EU market MDD 93/42/EEC directive (including CE Mark applications or self-declarations via technical files) along with Team Head
Responsible for maintaining and ensuring that the company quality system meets US FDA, ISO 13485, and all international market medical device requirements.
Responsible for ensuring that products and their labeling meet all regulatory requirements (national and international)
Responsible for the customer feedback /complaint system
Responsible for evaluating rejections and generating the evaluation report.
Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing.
Audit Design history files for new products for US FDA/ISO 13485/National Regulatory compliance
Responsible for reviewing and establishing the company quality goals each year along with Team Head.
Responsible for the Documentation Control Process and Documentation Change Control Process
Manage sterilization records and facilitation with contract sterilizer and 3rd party validation processes
Responsible for quality control and a quality system for Company’s products and products that we are the legal manufacturer
Establish an export compliance system
Identifying training and development needs and designing training modules to communicate quality and regulatory requirements.