Software Quality Specialist (fixed-term contract) - Spécialiste Qualité Logicielle CDD (H/F)

Job Description Summary

Dans ce rôle de Spécialiste Qualité Logicielle, vous serez chargé(e) de soutenir aux processus d’ingénierie conformément aux procédures et pratiques documentées. Il s’agit d’un rôle technique clé, responsable du développement, de la mise en œuvre, de l’amélioration et du renforcement continu des pratiques établies du Système de Management de la Qualité, des spécifications produits et des normes applicables. Vous collaborerez avec les équipes de conception, de transfert de conception, de fabrication, de distribution et de service. In this role as Software Quality Specialist you will be responsible for providing engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Management System practices, product specifications and applicable standards. You will collaborate within the areas of design, design transfer, manufacturing, distribution, and service.

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
• Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Developing in-depth knowledge of the product and processes. Uses prior experience and acquired expertise to execute functional policy/strategy.
• You will be an individual contributor, with demonstrated interpersonal skills. Communication with direct colleagues and the business about design and related processes (design transfer, manufacturing, distribution, and service). Provides guidance to team members and explains complex information to others in straightforward situations.
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, within a team environment focused on execution of activities/processes. Activities require professional judgment, but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

• Bachelor's degree from an accredited university/college or relevant work experience in Medical Devices, or similar regulated industry.
• Experience working in a regulated industry.
• Ability to communicate effectively in English (both written and oral). Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Desired Qualifications

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Experience in Quality Assurance, Quality Engineering, Design Engineering or Manufacturing Engineering in a regulated industry.
• Experience with Software as a Medical Device (SaMD)
• Demonstrated expertise to effectively communicate within different functions and different levels of the organization around QMS concepts including Design Controls, Risk Management and Product Quality.
• Demonstrated collaboration, negotiation, and conflict resolution skills.
• Demonstrated understanding of design change, document change control and manufacturing/production process change control processes and methodologies.
• Ability to demonstrate analytical, problem solving & root-cause analysis skills along with experience leading and implementing change.
• Ability to handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e., able to read & comprehend technical documentation & provide technical feedback)

Inclusion & Diversity Statement

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.