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As a trusted global transformation partner, Welocalize accelerates the global business journey by enabling brands and companies to reach, engage, and grow international audiences. Welocalize delivers multilingual content transformation services in translation, localization, and adaptation for over 250 languages with a growing network of over 77,000 in-country linguistic resources. Driving innovation in language services, Welocalize delivers high-quality training data transformation solutions for NLP-enabled machine learning by blending technology and human intelligence to collect, annotate, and evaluate all content types. Our team works across locations in North America, Europe, and Asia serving our global clients in the markets that matter to them. www.welocalize.com
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Main Duties
External and Internal ISO and Compliance audits
Prepare EU Business Units for annual registrar, client, and internal audits.
Conduct all EU Business Units annual registrar, client, and internal audits.
Issue and resolve NCRs, CAPAs, and Quality Improvement plans.
Perform Document Control functions for site QMS documents by authoring, revising, and distributing updates.
Implement and Monitor company-level Quality Control Plans, internal audits, processes, and procedures.
Collaborate with IT and Legal teams on compliance measures and initiatives.
ISSUE MANAGEMENT – CAPA SYSTEM
Coordinate and manage all aspects of the nonconformance, corrective and preventive action programs.
Help investigate, document, track and follow up on operational customer complaints.
Evaluate and determine the course of action for inspection activities that identify nonconformances.
Coordinate with management and facilitate meetings to resolve quality, production, and efficiency issues.
QMS
Serve as the regional functional expert on all QMS standards, policies, and procedures for cross-functional teams across global offices.
Consult with Site and Functional Area reps on implementation and monitoring of the QMS.
Coordinate and conduct QMS training for site employees to ensure compliance and understanding.
Help to maintain company's ISO Certifications
Requirements
ISO 9001 Lead Auditor Certified
Education: Bachelor's Degree
EXPERIENCE: 3-5 Years in ISO auditing, Localization/Services industry experience desired
MDR, Annex 11, Eudralex experience desired
Skills & Knowledge:
Experience with various QA/QC and/or trade tools, equipment, concepts, codes, and industry standards preferred;
Ability to effectively work across teams and functional areas
Excellent Verbal and Written communication
Strong Team Player
Six Sigma Green Belt Certified desired