About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. 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.
Role Summary: This position is responsible for providing quality engineering process support to GE Health Cloud in accordance with GE Healthcare Quality Management System (QMS). This key technical role is responsible for the development, implementation, improvement & continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in driving compliance activities around Software Development Projects including Health Cloud.
Essential Responsibilities: 1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. 2. Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance. 3. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. 4. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Scaled Agile Framework (SAFe), Agile/Lean methods, PRDx, etc. 5. Works with engineering teams closely to drive quality excellence of Health Cloud Platform and applications, including DHF documents review, design reviews, processes/practices simplification, QMS training, etc. 6. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). 7. Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process. 8. Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Qualifications/Requirements: 1. Bachelor's Degree in Engineering, Computer Science or equivalent 2. Minimum 2 years’ experience in Quality Assurance / Regulatory Affairs 3. Minimum 3 years’ experience in software within a regulatory industry 4. Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) 5. Experience with Agile/Lean software development methods 6Ability to effectively communicate technical information in English (both written and oral).
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required
Desired Characteristics: 1. Familiarity with medical device or healthcare software development environment with experience of design controls processes. 2. Familiarity with Agile/Lean software development lifecycle process. ScrumMaster experience is preferred. 3. Strong leadership and communication skills. Previous project management experience is preferred. 4. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. 5. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management.. 6. Demonstrated collaboration, negotiation & conflict resolution skills 7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance 8. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment. 9. Experience in a globalized working environment. 10. Experience leading and implementing change 11. Experience performing internal audits and participating in external audits 12. Exceptional analytical, problem solving & root-cause analysis skills 13. Ability to multi-task & handle tasks with competing priorities effectively 14. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.