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. Role Summary:
This Lead Quality Assurance Engineer position is the subject matter expert focused on software quality & compliance to the Quality Management System (QMS). He/she ensures each project meets or exceeds customer expectations and global regulatory requirements related to software. This is a key technical and leadership role that works closely with product management & engineering to ensure successful design, development, testing & release of the product. Essential Responsibilities:
1. Ensures program deliverables comply to the business imperatives, Quality Management System and applicable global standards.
2. Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
3. Drives continuous improvement activities focused on development processes or products.
4. Reviews & evaluates trends of software defects and recommends improvement actions.
5. Leads cross-functional product risk management activities.
6. Collaborates with cross-functional program teams to ensure timely release of products.
7. Leads programs and initiatives, and has responsibility for coaching other SWQE’s.
1. Bachelor's Degree in Computer Science, Engineering or similar technical discipline or strong relevant work experience. (or a Masters degree in Computer Science, Engineering or similar technical discipline in lieu of relevant work experience.)
2. Relevant work experience working in a regulated industry.
3. Ability to communicate effectively in English (both written and oral).
4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
1. Strong software development experience in a regulated industry.
2. Understanding of product software development lifecycles, software design change and document change control, software process verification and validation methodologies, and servicing in a medical device environment.
3. Understanding Medical Device QMS requirements including but not limited to FDA 21 CFR 820, EN 62304 and ISO 13485.
4. Expertise mentoring the organization in software design controls, Corrective & Preventive Action (CAPA), complaints, risk management & product quality improvement.
5. Demonstrated collaboration, negotiation & conflict resolution skills
6. Excellent communication skills (written and oral)
7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
8. Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
9. Change agent with energy, passion & enthusiasm to drive change.
10. Experience performing internal audits and participating in external audits
11. Exceptional analytical, problem solving & root-cause analysis skills
12. Ability to multi-task & handle tasks with competing priorities effectively
13. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.