Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies. Position Overview: As an Operations Quality Associate Quality Partner, your primary responsibilities will be supporting document control, equipment management activities and visual inspection of finished good products. You are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and to the ... more details
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
Position Overview:
As an Operations Quality Associate Quality Partner, your primary responsibilities will be supporting document control, equipment management activities and visual inspection of finished good products. You are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and to the companies Commitments. You work as a strategic business partner to help contribute more to the team, customers and patients and help mitigate significant compliance issues within your area of influence. Your contributions help lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.
Responsibilities:
Act as a Document Control coordinator (i.e. redlining documents, routing documents in electronic document management system, training users on document control process).
Support equipment management activities (i.e. scheduling vendors for calibrations, PM, and repairs, inducting new equipment, updating equipment status, monitoring equipment alarms).
Perform visual inspection of finished goods to ensure accuracy, completeness, appropriate release and control of products (review product information, generate Certificate of Analysis).
Support non-conformance investigations and corrective actions.
Compile and maintain Quality metrics to ensure compliance with quality system requirements and continuously promotes Right First Time.
Participate and implement process improvements to meet business needs. Drive innovation within your area of influence.
Responsible for performing activities as required to meet Operations Quality goals and objectives with direction as appropriate.
Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner.
Work day to day with limited supervision to correctly complete daily scheduled and unscheduled activities. Specific assigned tasks are completed independently.
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