Sr Lead Specialist Quality - Healthcare Quality

Job Description Summary 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.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description

• 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.

• This role requires working experience in computer system and software validation.
• Bachelors degree from an accredited university or college with at least 7 years of experience in Quality assurance domain.

• 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 .

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