Quality Assurance Manager

Summary:

Quality Assurance Manager – Document Control & Training is responsible for leading the Document Control and Training team while managing the organization's Quality Management System (QMS). This role ensures compliance with ISO 13485, FDA regulations, and other applicable standards by maintaining robust document control processes, overseeing employee training programs, and driving continuous improvement initiatives. The position responsible for supporting audits, regulatory inspections, and cross-functional collaboration to uphold quality and regulatory requirements.

Essential Duties and Responsibilities:

Lead Document Control and Training Team

• Oversee the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS).
• Ensure timely document revisions and compliance with regulatory and internal requirements.
• Manage training programs to ensure employees are trained on applicable...