Contract/term position providing general project management support for class III medical device development. Job responsibilities include meeting facilitation, leadership, minutes/agendas, status reporting and management of critical path,...

• Create (from-scratch) and/or significantly rewrite documents including but not limited to design history files, design verification records, and master production records. • Master technical information, organize content, and imbed GxP compliance •...

SUMMARY: Responsible for the design, documentation, implementation and execution of data collection and data quality review in clinical research studies. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Provide expertise in data management to support...

Evaluate and approve deviations and CAPA. Respond to deviations with corrective and preventive actions that will prevent recurrence and result in deviation reduction. Partner effectively with Manufacturing and QC to meet deviation and release...