GE HealthCare Sr Lead Specialist Quality - Healthcare 

India, Karnataka 

27080538

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

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

• Responsible to review and approve CSV deliverables to ensure tools and systems supported by Healthcare IT teams are validated in compliance to applicable QMS procedures.

• Resolves issues using established procedures and collaborate with Healthcare IT teams to drive Corrective and preventive actions.

• Collaborates with Cross functional teams in problem solving through structured and technical approach.

• Understand external trends and potential ramifications for the supported IT area(s)

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