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GE Healthcare Sr Lead Specialist Quality - Healthcare Quality in Bengaluru, India

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

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 computer system 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.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are 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

Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud

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Additional Information

Relocation Assistance Provided: No

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