QMS Specialist I

Job description

Job Overview

The SmartSolve Administrator is responsible for supporting users of SmartSolve eQMS system within TE Medical. This role will work closely with the Global Software Compliance Team. This person will support cross-site activities, drive best practice adoption, and project rollouts.

Responsibilities

Resolves TEIS Helpdesk tickets in line with business Service Level Agreement timelines while providing exceptional customer service Provides training to users on best practices in eQMS / PLM system as needed using self-generated training materials. Troubleshoots eQMS Technical Issues and escalates issues to Module SMEs, Software owner, software vendor ticket system, and QMS Leads as appropriate. Contributes to eQMS System integration and harmonization activities for new sites and businesses as acquired.

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues. Takes part in Global Compliance projects defined by the Global Software Compliance team. Recommends and implements changes/enhancements to eQMS software to address repetitive issues and process improvements. Ability to work flex work hours as needed to support global sites across time-zones Reporting directly to the Global Sr Quality Systems Engineer. (May change at the company’s sole discretion.) Other duties as assigned.

Candidate Desired Profile

Minimum of 2 years’ related experience working at a progressively responsible level. Well organized with a strong ability to prioritize tasks and works on own initiative through independent judgement and is effective with minimal supervision. Good written and verbal communication skills. Working knowledge of IT ticket systems and software concepts, including SaaS, preferred. Working knowledge of quality systems, ISO 13485:2016 preferred.

Fluent in English. Spanish fluency is an advantage. What your background should look like Generally requires Bachelors degree in appropriate field or local equivalent.