Quality Assurance Engineer

Job description

3111323
Additional Cities

Bengaluru
Career Level

Entry-Level
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

India
Postal Code

560066
Role Summary/Purpose

This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of Manufacturing, design transfer, distribution, and/or service.
Essential Responsibilities

1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site..
3. Supports continuous product and process improvement through detailed failure analysis for non-conformance, 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).
4. Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
5. 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 in Engineering or Masters degree in Science
2. Minimum of 1 year experience working in a regulated industry
3. Ability to communicate effectively in English (both written and oral).
Desired Characteristics

1. Minimum of 1 year 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
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.
Primary Country

India