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 market
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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
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
Bachelors degree in Engineering with minimum 10 years of experience as a Quality Assurance professional in Healthcare Industry
Experience in the application of QMS and Compliance requirements related to Design Controls in accordance with ISOCFR Part 820 IEC 62304 ISO 14971 EU MDR IMDR and other regulations
Excellent Leadership Communication Collaboration and Negotiation skills
Ability to deliver in a matrix organization which includes regional and global teams
Demonstrated ability in application of problem-solving techniques and tools
Result oriented with customer centric mindset
Desired Characteristics
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.
Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 IEC 62304-2006 (Medical Device Software) and ISO 13485.
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 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.
#LI-RS1
Additional Information
Relocation Assistance Provided: No
Required Experience:
Manager
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;...
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 market
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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
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
Bachelors degree in Engineering with minimum 10 years of experience as a Quality Assurance professional in Healthcare Industry
Experience in the application of QMS and Compliance requirements related to Design Controls in accordance with ISOCFR Part 820 IEC 62304 ISO 14971 EU MDR IMDR and other regulations
Excellent Leadership Communication Collaboration and Negotiation skills
Ability to deliver in a matrix organization which includes regional and global teams
Demonstrated ability in application of problem-solving techniques and tools
Result oriented with customer centric mindset
Desired Characteristics
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.
Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 IEC 62304-2006 (Medical Device Software) and ISO 13485.
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 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.
#LI-RS1
Additional Information
Relocation Assistance Provided: No
Required Experience:
Manager
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