Software Quality Specialist (fixed-term contract) - …, Buc

Overview

Dans ce rôle de Spécialiste Qualité Logicielle, vous serez chargé(e) de soutenir les processus d’ingénierie conformément aux procédures et pratiques documentées. In this role as a Software Quality Specialist you will be responsible for providing engineering process support in accordance with documented procedures and practices. You will collaborate with the design, design transfer, manufacturing, distribution and service teams.Responsibilities

Develop a quality culture by driving compliance activities around a specific product, site or region. Own the overall Quality Management System for the activity and monitor quality indicators. Ensure quality and regulatory compliance while driving process effectiveness and efficiency. Represent GE HealthCare to external agencies and champion the evolution of the quality culture.Acquire in-depth knowledge of the product and processes. Apply experience and expertise to execute functional policy and strategy. Communicate with direct colleagues and the business about design and related processes (design transfer, manufacturing, distribution, and service). Provide guidance to team members and explain complex information in straightforward situations.Impact projects, processes and procedures within your field. Operate with some autonomy within a team oriented to execution of activities and processes; may require senior-level guidance. Leverage technical expertise and analytical thinking to solve problems; may use multiple internal sources 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 (written and oral). Proficiency with MS Office applications (Word, Excel, PowerPoint, and basic database tools).Desired Qualifications

Demonstrated understanding of Medical Device QMS requirements and regulatory requirements, including FDA CFR 21 Part820 and ISO13485. Experience in Quality Assurance, Quality Engineering, Design Engineering, or Manufacturing Engineering in a regulated industry. Experience with Software as a Medical Device (SaMD).Effective communication skills across different functions and organization levels around QMS concepts such as Design Controls, Risk Management, and Product Quality. Collaboration, negotiation and conflict resolution skills. Understanding of design change, document change control and manufacturing/production change control processes.Analytical, problem‑solving and root‑cause analysis skills; experience leading and implementing change. Ability to handle tasks with competing priorities effectively. Strong technical aptitude (read, understand and provide technical feedback on technical documentation). Equal Opportunity Employment

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.

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