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General Electric Company

QA Site Leader

General Electric Company - Sacramento, CA

**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 at EEO combined.pdf . 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 provides process support in accordance with documented procedures & practices. He/she develops the strategy for program teams to meet compliance requirements and is responsible for the development, implementation and improvement of QA practices. The role may involve work in design, design transfer, manufacturing, distribution, and service.

**Essential Responsibilities:**

1. Leads quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility for the site and overall Healthcare Digital business. 2. Develops, implements, and continuously improves process effectiveness and efficiency at the site. 3. Focal point of contact for the QA team for all escalations related to quality assurance, and acts as the primary QA contact for site compliance activities. 4. Ensures 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 simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts. 5. Identifies and influences 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). 6. Utilizes and shapes the 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. 7. Interfaces with site leadership on various initiatives. 8. Leverages metrics to assist in shaping the strategy of the assigned area of responsibility. 9. Manage the site internal audit process, and act as lead auditor for the business. 10. Performs a broad variety of tasks in support of product and process quality as assignment by the departmental manager.


1. Bachelor's Degree or a minimum of 10 years work experience. 2. Minimum of 5 years working in a regulated medical device or pharmaceutical 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. 5. Experience managing project teams. 6. 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.

**Desired Characteristics:**

1. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485 and MDSAP audit models. 2. Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry or experience in design engineering or manufacturing engineering in the medical device field. 3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes 4. 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; & product quality improvement using tools such as six sigma, DFR, etc. 5. Demonstrated collaboration & 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 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 and 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.

**Locations:** United States; California, Washington; Seattle, San Ramon

GE will only employ those who are legally authorized to work in the United States for this opening.

16 days 3 hours ago

General Electric Company


QA Site Leader General Electric Company - Sacramento, CA, United States


Location: Sacramento, CA

Company Profile:
GE {NYSE: GE} works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works.