Quality Operations Specialist

Quality Operations Specialist

Novocure

Krakow, Poland

The Quality Operations Specialist is a Subject Matter Expert (SME) responsible for managing device labeling (including, but not limited to labels and UDI) as necessary to market and clinically test Novocure medical devices.

Your responsibilities:

• Responsible for establishing a robust, effective and efficient process for managing changes in Novocure products labels
• Identify solutions for the Clinical, NPI and Sustaining labeling change request requirements
• Responsible for implementing and maintaining the effectiveness of the quality system by delivering the “perfect label” through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to Novocure
• Scope of label changes includes Regulatory Affairs for labeling submissions, Novocure OCs, third party manufacturers and third party partners
• Complete work according to established priorities, policies, practices and procedures to assure deliverables meet requirements
• Collaborate and communicate with key stakeholders in the label change process for production and submission artwork to prioritize deliverables
• Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates
• Interact with key stakeholders such as Regulatory Affairs and NPI, as needed, to successfully execute label change requests and proofreading for the verification of developed label copy against the source documents
• Ensure tasks are completed according to Right First Time principles
• Evaluate the impact of a label change on associated labels and manufacturing operations
• Ensure completeness, accuracy, and control of changes in labeling including maintenance of labeling related specifications and documentation associated with these specifications
• Work closely with NPI in the creation of label artwork, mock ups utilized for regulatory submissions, and assist commercial/clinical , as required, in the development of label designs for packaging and labeling commodities
• Lead sections of process improvement projects and propose solutions. Identify and define gaps, revise verbiage to clarify, improve/enhance and/or correct relevant procedures and provide guidance and training as needed

Your profile:

• Bachelor’s Degree in Business/Engineering/Sciences preferred. Equivalent successful industry experience (minimum 2 years) can be considered
• Training evidence for Quality Management System Standards and Regulations
• Knowledge of applicable international regulations and standards affecting Device Products, specifically regulations and standards affecting the Packaging and Labeling Quality System is a plus
• Fluency in English, written and spoken is essential as this will be the primary working language

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