Sr Quality Engineer

Job Description
Insight Global is seeking an experienced, highly skilled Sr Quality Engineer to support an established medical supply client out of Redmond, OR.

Key Responsibilities:
Develop and implement procedures for QMS, process control, validation, improvement, testing, and inspection.
Partner with suppliers to resolve quality issues, ensuring corrective actions (CAPA, SCAR) are implemented.
Provide Quality expertise in Product Development, Design Control, Risk Management, Validation, and QMS processes.
Build and maintain Device Master Records (DMRs) in compliance with regulations.
Collaborate with Regulatory Groups and internal departments to support 510K submissions and related documentation.
Ensure compliance with domestic and international regulations.
Perform quality reviews of design documentation, validation documentation, and company quality records.
Lead investigations of product/process non-conformances and out-of-specification results...

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