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Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryOlympus is seeking a Senior Quality Engineer to lead activities related to design transfer planning, change management, and ensure development projects are transitioned to repair & service facilities by defining success KPIs, ensuring risk measures and requirements are flowed down to repair sites, repair processes developed & qualified for...
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Senior Quality Engineer
vor 4 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitAbout the RoleWe are seeking a Senior Quality Engineer to join our team at Olympus Medical Systems Division. As a key member of our quality organization, you will be responsible for leading activities related to design transfer planning, change management, and ensuring development projects are transitioned to repair & service facilities.Key...
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Hamburg, Hamburg, Deutschland Horváth VollzeitWe are seeking a highly skilled Senior Software Engineer to join our team. The successful candidate will be responsible for designing and developing high-quality code for our software applications. This is an excellent opportunity for an experienced software engineer to take on new challenges and contribute to the growth of our company.Key...
Senior Quality Engineer
vor 1 Monat
About the Role
Olympus is seeking a Senior Quality Engineer to lead design transfer planning, change management, and ensure development projects are transitioned to repair & service facilities. The ideal candidate will have a strong background in U.S. FDA QSR, ISO 13485, MDD, EU MDR, and ISO 14971.
Key Responsibilities
- Lead design transfer planning and change management activities
- Ensure development projects are transitioned to repair & service facilities
- Develop and implement global quality standards and processes
- Collaborate with global repair & service sites to create, develop, and maintain quality standards
- Gain a deep understanding of the system and leverage this knowledge to drive continuous improvement
Requirements
- Bachelor's degree in an engineering discipline required; a Master's degree is preferred
- Over 5 years of experience in the medical device industry, with a focus on operations, design, or quality engineering
- Strong expertise in U.S. FDA QSR, ISO 13485, MDD, EU MDR, and ISO 14971
- Excellent verbal and written communication skills, including the ability to generate technical reports and present to management
About Olympus
Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. We are committed to making people's lives healthier, safer, and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety.
