Program Manager Quality Assurance India SA
Program Manager Quality Assurance India SA
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Job Description
Job Description Summary
Develop 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 marketJob 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 indepth 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 daytoday 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 ISOCFR and Risk Management for Medical devices
- Monitoring and improvement of key service performance indicators
- Ensuring compliance to quality and regulatory requirements
- Customerfocused in defining quality and establishing priorities
- Proficient in the soft skills necessary to be an effective program manager
- Proven leadership and effective decisionmaking 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 indepth 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 welldefined 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 daytoday 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 Bachelors 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 Bachelors 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 worldchanging realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll 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: Information Relocation Assistance Provided: No
Required Experience:
Manager
Employment Type
Full-Time
