Description
The Senior Quality Assurance Specialist at A-dec is responsible for managing and maintaining the company's Quality Management System (QMS), ensuring audit readiness and compliance with medical device regulations like US-FDA, Health Canada, and the European Union. This involves leading internal audits, liaising with external auditors, executing key quality processes such as CAPA and Audit Programs, and continuously improving business processes. The specialist acts as a technical subject matter expert, manages audit results, supports management reviews, participates in complaint and CAPA review boards, identifies continuous improvement initiatives, coaches junior specialists, and delivers training.
