job title: Associate specialist - healthcare quality(GE healthcare)

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.

• Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.

• Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.

• May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.

• A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others.

Required Qualifications

• This role requires basic experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).

• Minimum 2-3 years of experience in Software and IT tools Quality assurance

• Knowledge on Medical device regulations and standards not limited to ISO13485, FDA 21 CFR Part 11, 21 CFR 820

• Experience in Change Management and Computerized system Validations

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

• Strong Project management skills and interpersonal skills to manage and communicate along with cross-functional teams .