Senior Quality Assurance Specialist

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