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Herlev Kommune, Region Hovedstaden, Danmark
Onsite
Available
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.
Manages small to medium size team of quality professionals. Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.
Provides leadership and direction for quality initiatives, including product quality improvements and acts as the management representative in quality audits and supporting customer relations.
May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on particular topics. May guide others to consider a different point of view.
Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
Bachelor's Degree in a scientific discipline; Master’s in Science or Business Administration preferred; and extensive working experience in the medical device industry and/or regulated industry
Demonstrated understanding or aptitude in Medical Device QMS requirements and international regulatory requirements including but not limited to FDA 21 CFR820, 803, 806, ISO 13485, and EU MDR Regulation 2017/245.
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, Smartsheet, and database applications.
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.
Thorough understanding of quality management systems, with strong domain expertise in Design Controls, Software Development, and Risk Management
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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Relocation Assistance Provided: Yes
