Quality Lead Specialist

Job description

3185693
Additional Cities

Florence
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
Additional States/Provinces

South Carolina
Postal Code

29501-7806
Role Summary/Purpose

This is a key compliance role primarily responsible for QMS implementation, continuous improvement, and reinforcement of established QMS documents that are utilized in the local business. The role involves hands-on work in the areas of regulatory compliance, documentation controls, design controls, purchasing controls, production and process controls, product quality, distribution, and/or training.
Essential Responsibilities

Perform impact assessments on Florence local documents when Global Work Instructions and Procedures or Global regulations change. 2. Revise, route, ensure training is complete, and release QMS documents per the global effectivity dates. 3. Develop and/or revise procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation as required. 4. Assists in ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. 5. Leads, develops, communicates, and implements a strategy to ensure QMS compliance. 6. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. 7. May support product and process improvement through detailed failure analysis for non-conformances, investigations or CAPAs. Support root cause analyses, actions plans, implementation activities, and perform effectivity checks as required. 8. Utilize risk management tools and aids in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts
Qualifications/Requirements

1. Bachelor's Degree or a minimum of 4 years of related 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.
Desired Characteristics

1. Minimum of 3 years experience in a regulated industry is preferred 2. 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. 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, negotiation & conflict resolution skills 6. Excellent communication skills (written and oral) .
About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual 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.
Additional Eligibility Qualifications

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

United States
Primary State/Province

South Carolina
Primary City

Florence