Localization Specialist

Required Skills & Experience

Requirements:\n\nMinimum required Education: High School Diploma or equivalent.\nMinimum required Experience: Strong attention to detail and organizational skills. Basic computer and documentation skills. Ability to read and follow written procedures and work instructions.\nMinimum required Certification: N/A\nAdditional Requirements:\nAbility to work in a fast-paced environment while maintaining quality standards.\nAbility to stand, walk, bend, and lift materials throughout the workday.

Nice to Have Skills & Experience

Preferred Qualifications & Skills:\n\nPreferred Education: N/A\nPreferred Experience: Previous warehouse, manufacturing, medical device, packaging, or logistics experience. Experience working in a regulated environment. Experience with product labeling, packaging, or rework activities.\nPreferred Certification: N/A\nPreferred Skills:\nKnowledge of Good Documentation Practices (GDP) and quality systems.

Job Description

Job Responsibilities:\n\nPerforms approved localization and rework activities in accordance with established procedures and work instructions.\nRemoves, replaces, and applies product labels, Instructions for Use (IFUs), and packaging components as required.\nVerifies product configuration, lot numbers, serial numbers, and documentation to ensure product traceability.\nCompletes Device History Records (DHRs), rework documentation, and associated records accurately and in real time.\nPerforms visual inspections to verify labeling accuracy, packaging integrity, and product configuration.\nStages, organizes, and manages materials required to support localization and rework operations.\nMaintains segregation and control of released, on-hold, and nonconforming product.\nIdentifies and escalates quality, inventory, documentation, or process-related issues to leadership and Quality personnel.\nFollows Good Documentation Practices (GDP), safety requirements, and applicable quality system procedures.\nMaintains a safe, clean, and organized work environment.\nCollaborates with Operations, Quality, Planning, and other cross-functional teams to support business objectives.\nParticipates in required training and maintains necessary qualifications to perform assigned duties.\nSupports overtime and schedule flexibility as needed to meet project timelines and business requirements.