Quality Systems Manager

A Global Job Position With An Impact

The Quality Systems Manager is responsible for the oversight, implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS) to ensure compliance with applicable regulatory requirements. This role ensures quality system processes are effective, audit ready, and aligned with business and risk based decision making objectives.

Duties/Responsibilities

• Responsible for managing and monitoring core QMS processes, including document control, change control, CAPA, nonconformances, planned deviations, training, and internal audits.
• Ensure the QMS is implemented and maintained in compliance with current regulations and standards according to ISO 13485 and 21 CFR Part 820, and other applicable regulations.
• Lead and support regulatory inspections and audits (Notified Bodies, UL, and Corporate), including preparation, execution, and response to observations.
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