Job Overview

The Quality Systems Engineer will drive Software Implementations and improvements projects at a Global level 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.

Job Requirements

Job Responsibilities

•    Manages Projects for Software Implementation for globally owned quality systems software
•    Works on selected process improvement initiatives with a focus to standardize processes across all sites
•    Creates Work Breakdown Structures with assignees and timelines to provide a roadmap to achieve project and initiative deadlines
•    Provides training on best practices to maintain regulatory compliance and effective quality practices as needed using self-generated training materials.
•    Prepares documentation for projects including updates to procedures and work instructions
•    Contributes to eQMS System integration and harmonization activities for new sites and businesses as acquired.
•    Takes part in Global Compliance projects defined by the Global Software Compliance team.
•    Works well with cross-functional and cross-site teams to improve quality system procedures and practices.
•    Able to work flex work hours as needed to support global sites across time-zones
•    Reporting directly to the Global Software Compliance Manager. (May change at the company’s sole discretion.)

What your background should look like

Minimum Experience/Qualification:
•    Bachelor’s Degree with a scientific or engineering emphasis. 
•    Minimum of 2 years’ related experience working at a progressively responsible level. 
•    Working knowledge of software concepts, including SaaS.
•    Working knowledge of quality systems, ISO 13485 preferred.
•    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.
•    Fluent in English, Spanish is an advantage.
•    Creative and innovative thinking skills.

Competencies