Quality Engineer (Systems & Compliance)

_Suvoda is looking for a Quality Engineer to join our team and help ensure the quality, reliability, and performance of our solutions. In this role, you’ll collaborate with cross-functional teams to support quality assurance activities, identify opportunities for improvement, and contribute to delivering high-quality products that meet our standards and customer expectations.

_Responsibilities

• Manages and facilitates all stages of the Quality Event Management process, including but not limited to, conducting incident/issue investigations, assessing risk/impact, conducting trend analyses, and defining and tracking corrective and preventive actions and associated effectiveness checks.
• Conducts Quality Event Investigations by facilitating and completing root cause analyses: working internally with cross-functional teams to collect and analyze relevant data, utilizing and applying RCA tools (such as flowcharts, fish bone diagrams, 5-Why's analysis, etc.) and ensuring that investigations are conducted in accordance with a GCP-regulated environment. Applies CAPA disciplines to develop effective corrective and preventive action plans.
• Performs quality event trend reviews and facilitates analyses, escalating observations when deemed warranted by QMS process.
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