Quality Specialist

Job description

3193185
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 role is primarily responsible for Quality Management System (QMS) implementation, Document Controls, and administrative tasks related to revising, routing, and releasing documentation by the prescribed deadlines. Working in conjunction with the Site Training Leader to ensure training completion is considered prior to releasing documents. Act as Junior Librarian in the Document Control database (Administrator). Assist with Document security. Filing as required.
Essential Responsibilities

1. With assistance of the applicable Subject Matter Expert (SME), compete impact assessments on Florence local documents when Global Work Instructions and Procedures or Global regulations change. 2. Complete impact assessment actions which includes revising, routing, ensuring training is complete, and releasing QMS documents per the global effectivity dates. 3. Develop and/or revise procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other production 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. Update affiliate interface agreements as needed.
Qualifications/Requirements

1. Bachelor's Degree or a minimum of 3 years of related work experience in Office Administration activities, Documentation Controls, and/or data entry. 2. Minimum of 1 year 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.
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. Excellent communication skills (written and oral). 5. Experience with MyWorkshop
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