Description
Job Title: Localization Specialist
Job Responsibilities:
- Performs approved localization and Phoenix rework activities in accordance with established procedures and work instructions.
- Removes, replaces, and applies product labels, Instructions for Use (IFUs), and packaging components as required.
- Verifies product configuration, lot numbers, serial numbers, and documentation to ensure product traceability.
- Completes Device History Records (DHRs), rework documentation, and associated records accurately and in real time.
- Performs visual inspections to verify labeling accuracy, packaging integrity, and product configuration.
- Stages, organizes, and manages materials required to support localization and rework operations.
- Maintains segregation and control of released, on-hold, and nonconforming product.
- Identifies and escalates quality, inventory, documentation, or process-related issues to leadership and Quality personnel.
- Follows Good Documentation Practices (GDP), safety requirements, and applicable quality system procedures.
- Maintains a safe, clean, and organized work environment.
- Collaborates with Operations, Quality, Planning, and other cross-functional teams to support business objectives.
- Participates in required training and maintains necessary qualifications to perform assigned duties.
- Supports overtime and schedule flexibility as needed to meet project timelines and business requirements.
Requirements:
- Minimum required Education: High School Diploma or equivalent.
- Minimum required Experience: Strong attention to detail and organizational skills. Basic computer and documentation skills. Ability to read and follow written procedures and work instructions.
- Minimum required Certification: N/A
- Additional Requirements:
- Ability to work in a fast-paced environment while maintaining quality standards.
- Ability to stand, walk, bend, and lift materials throughout the workday.
Preferred Qualifications & Skills:
- Preferred Education: N/A
- Preferred Experience: Previous warehouse, manufacturing, medical device, packaging, or logistics experience. Experience working in a regulated environment. Experience with product labeling, packaging, or rework activities.
- Preferred Certification: N/A
- Preferred Skills:
- Knowledge of Good Documentation Practices (GDP) and quality systems.
Position Details:
- Justification: Temporary resource needed to support the critical Phoenix rework initiative, which has an estimated business impact of approximately €1.5 million. Dedicated headcount is required to execute product relabeling, IFU replacement, packaging updates, and traceability documentation accurately and compliantly. These temporary resources will accelerate project completion, mitigate the risk of delaying inventory recovery, and ensure day-to-day localization operations and customer demands are not disrupted.
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