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 being 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 role that works closely with product management & engineering to ensure successful design, development, testing & release of the product.
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 Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
5. Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
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.
9. If managing a team, provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable.
10. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Qualifications/Requirements: 1. Bachelor's Degree or a minimum of 4 years work experience.
2. Minimum of 1 year experience working in a regulated industry or a Masters degree
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.
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. Minimum of 5 years 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.
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 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. Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
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.
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