Job Description
Description
Position Summary
The Principal Quality Management System Engineer will be responsible for transferring a stand‑alone quality management system (QMS) as part of a business separation or organizational restructuring. This role leads quality system and PLM change management activities, ensuring compliant extraction, migration, and consolidation of quality processes, documentation, and product data from a shared or embedded environment into a new or hybrid QMS. The position requires strong regulatory knowledge, cross‑functional leadership, and end‑to‑end understanding of medical device quality systems.
Key Responsibilities
Quality System Separation & Stand‑Up
Lead the design and implementation of a stand‑alone or hybrid quality management system that is currently embedded within a larger parent organization’s quality framework.
Develop a deep understanding of the existing, intertwined quality system and define the strategy to extract, adapt, and/or create qual...
Position Summary
The Principal Quality Management System Engineer will be responsible for transferring a stand‑alone quality management system (QMS) as part of a business separation or organizational restructuring. This role leads quality system and PLM change management activities, ensuring compliant extraction, migration, and consolidation of quality processes, documentation, and product data from a shared or embedded environment into a new or hybrid QMS. The position requires strong regulatory knowledge, cross‑functional leadership, and end‑to‑end understanding of medical device quality systems.
Key Responsibilities
Quality System Separation & Stand‑Up
Lead the design and implementation of a stand‑alone or hybrid quality management system that is currently embedded within a larger parent organization’s quality framework.
Develop a deep understanding of the existing, intertwined quality system and define the strategy to extract, adapt, and/or create qual...
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