Program Manager, Quality Assurance, India & SA

Job Description SummaryDevelop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

Job Description

Roles and Responsibilities

In this role you will:

• Create 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.
• Ensure 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.
• Utilize in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
• Act as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field.
• Use some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking.

• Drive regional efforts to improve product quality and quality system, to improve customer experience, regulatory compliance and quality culture.

• Green Belt / Black Belt certified or familiar with Six Sigma quality concepts and tools
• Knowledge of ISO 13485, ISO 14971, ISO 17025, 21CFR and Risk Management for Medical devices
• Monitoring and improvement of key service performance indicators
• Ensuring compliance to quality and regulatory requirements
• Customer-focused in defining quality and establishing priorities
• Proficient in the soft skills necessary to be an effective program manager
• Proven leadership and effective decision-making capabilities
• Demonstrated experience in leading multicultural and remote teams
• Experience in Driving Quality and Compliance Programs for the larger organisation.

• GEHC ONLY 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.
• Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
• Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
• Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
• Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Required Qualifications

• This role requires 15 plus years of advanced experience in 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).

• Experience in Product Quality, QMS/Medical Device Industry expertise
• Experience in service, technology or operations, preferably in Healthcare Business
• ISO 13485:2016 Qualified Auditor/Lead auditor experience for Medical devices
• Strong proficiency in ISO 13485 and regulatory requirements for Medical devices
• For roles outside of the USA- This role requires advanced 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).

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

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

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