GE HealthCare Sr Lead Specialist Quality - Healthcare 

India, Karnataka 

430373395

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures the Functional and Program deliverables are in compliance with applicable Computer System Validation procedures. May include support roles with specialized expertise or technical knowledge in broad area.

Roles and Responsibilities

• Establish and maintain the QMS framework for Healthcare IT function.

• Ensures QMS compliance while driving process effectiveness and efficiency for Healthcare IT team.

• Lead the training management element wrt Establishing training plan, training assignments and monitoring training metrics for Healthcare IT teams.

• Support and maintain the Quality KPIs by analyzing and trending through QMRs and related op-mechs to achieve QMS goals and objectives.

• Ensure Internal audits execution in accordance to applicable QMS procedures for Healthcare IT teams.

Required Qualifications

• This role requires working experience in computersystem and software validation.

• Bachelor's degree from an accredited university or college with at least 7 years of experience in Quality assurance domain.

Desired Characteristics

• Knowledge of ISO13485 and regulatory standards FDA 21 CFR, part 11 compliance applicable for medical device industry.

• Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate.

total rewardsare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support