A company is looking for a Senior Quality Assurance Specialist to support the development of a digital quality management system.
Key Responsibilities
Manage collaboration on process improvement and sustainment of QMS processes across Operations and R&D
Lead Digital QMS audit & inspection readiness, deviations, and change control activities
Oversee documents / records within the Quality Management System and manage external contractors
Required Qualifications
Strong knowledge and experience in Medical Device Quality System Regulations and Standards
Previous experience managing Quality Management System Requirements and Regulatory Requirements
Experience supporting pre-clinical, clinical research, and / or pharmacovigilance activities
Experience in project management, process improvement, and quality system management
Ability to work on multiple projects in a deadline-driven environment
Quality Assurance Specialist • Manchester, New Hampshire, United States