The UDI Labeling Quality Control Specialist will support the review and implementation of quality system elements and product labels with respect to compliance with Global UDI requirements.
This role will operate as a key team member of a focused team implementing Global UDI infrastructure across key sites (virtual visits).
At each site, this team will work with various functional teams (R&D, marketing, regulatory, quality, engineering, manufacturing) on quality system elements and labeling requirements and analysis related to global UDI Implementation for Client medical devices.
The UDI Labelling Quality Control Specialist will interact with various Business Unit stakeholders. The role will be accountable for the delivery of the successful execution of the assigned UDI Tiger Team task ensuring an achievable and successful outcome.
This job function has accountability for complying with the applicable elements of the Division Quality System procedures, and the Division project management methodology.
Essential Duties and Responsibilities (Key Activities)
Carries out duties in compliance with established business policies and procedures.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
Assist Project Manager as a Tiger Team Member in daily activities related to the UDI implementation and maintenance activities, as assigned.
Quality Management System Alignment: Review and redline legacy site quality management system documentation to align with Divisional Global UDI SOP requirements.
Label Verification: Ensure data accuracy between labels and master UDI data and global UDI labeling requirements consistently implemented.
Works with other functions to identify and resolve labeling inconsistencies with UDI requirements to meet project objectives. Redline and update labeling, as required.
Manage UDI label change controls to plan, prepare and submit complete and accurate change requests within a PLM system/Client's Agile Quality Management System. While ensuring the correct implementation strategy is applied.
Support Project Manager during project execution with various data-related needs.
Collaborate, communicate, and provide status to key stakeholders.
Maintainability to comply with a business continuity plan (i.e., Work remotely).
Provide input and participate in writing procedures and other documents.
Desirable (Not Essential):
5-7 years of Quality and Regulatory Affairs experience.
Strong technology awareness in line with technologies in use across the Division (e.g., Oracle Agile PLM, DocXellent ensure, SalesForce.com and SharePoint).
Experience in leading and implementing change initiatives with design controls.
Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting the approach to suit the audience.
Attention to details by documenting meetings, action items, and objectives.
Bachelor's degree (BS) in a relevant discipline i.e., engineering, packaging/labeling.
Minimum 3-5 years of experience required working in a quality system within a regulated environment.
Experience with the design and implementation of UDI for medical device units.
Must have knowledge and experience of quality system elements and how they interact – direct Global UDI system experience preferred.
Must have experience and knowledge of how to determine the feasibility of adding GS1 UDI to a device, including experience of UDI labeling requirements and practical considerations.
Must be knowledgeable of Global UDI and GS1 standards and requirements.
Requires a high level of attention to detail, and project management skills.
Requires working knowledge of Barcoding systems and UDI requirements.
Requires knowledge of label printing applications and ERP systems.
Must demonstrate the application of advanced problem-solving methodologies, be detail-oriented, a critical-thinker, and experienced at investigating and resolving complex issues.
Must demonstrate an advanced understanding of the principles of good technical writing.
Must be computer literate, proficient in MS Word, PowerPoint, Excel, and Outlook.
Must have strong written and verbal communication skills and demonstrated ability to work cross-functionally.
Must have the ability to take ownership, organize workload and change priorities quickly.
Must be able to assume responsibility and accountability for daily tasks and highlight any risks to the Supervisor.
Must have the ability to maintain focus and drive to deliver results on committed timelines.
International exposure and experience, operating across multiple time zones.
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