Job Description

Responsibilities

+ Conduct DMR remediation activities in alignment with internal procedures and regulatory requirements.

+ Create, revise, and maintain controlled technical documentation, including drawings, design documents, specifications, and change orders.

+ Update and maintain firmware specifications, ensuring accuracy, traceability, and alignment with engineering and quality requirements.

+ Review existing technical documents to identify gaps, inconsistencies, and required updates; drive changes through formal change control.

+ Collaborate with engineering, quality, supply chain, and other stakeholders to clarify requirements and ensure completeness.

+ Follow design control workflows and documentation standards within a regulated environment.

+ Support continuous improvement of documentation and configuration management processes.

Essential Skills

+ Experience in document control and technical docume...

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