Working for our blood products group on product development activities such as design controls, risk management, stability, and container closure studies

Biologic/Drug/Blood Product: Working on new Biologic/Drug/Blood product development from a quality perspective, continuing the growth of this space in our company. Familiar with combination product and investigational new drug application requirements and regulations, and working to provide objective evidence that new products are safe and effective. Part of team developing cGMP Quality System to meet the specific regulations for these products.Medical Device: Working with new medical device development from a quality perspective, working to ensure design, process, and use features are adequately assessed for risk during development phases and ensure design inputs and outputs are adequately defined, verified, and validated. Determining key quality attributes for incoming components to ensure final device design performance requirements are met. Performing all required quality and regulatory tasks and providing assistance to obtain FDA and/or Rest of World regulatory approval of devices.

Worked with new medical device development from a quality perspective, working to ensure design, process, and use features are adequately assessed for risk during development phases. Performing all required quality and regulatory tasks and providing assistance to obtain FDA and/or Rest of World regulatory approval of devices. Running development projects as Project Manager, keeping track of team tasks and planning development timelines.

Worked with new medical device development from a quality perspective, working to ensure design, process, and use features were adequately assessed for risk during development phases. Supported manufacturing lines of currently marketed medical devices, providing changes or assessment to minimize manufacturing line errors.

Perform regular analytical release testing on medical devices.Support research and development departments with characterization, design verification, and qualification of new devices.Perform installation and operational qualification for incoming instrumentation for test laboratories.Coordinate biocompatibility tests for device projects.Technical report writing to document device stability, method validation, device qualifications, and biocompatibility evaluations.