Senior Quality Engineer
vor 2 Wochen
About the Role
We are seeking a seasoned Senior Quality Engineer to join our Medical Systems Division at Olympus. In this pivotal role, you will lead design transfer planning, change management, and ensure development projects are successfully transitioned to repair & service facilities. Your expertise will be crucial in defining success KPIs, ensuring risk measures and requirements are flowed down to repair sites, and developing qualified repair processes.
Key Responsibilities
- Lead and support repair sites to address quality issues and resolution using quality techniques and principles.
- Collaborate with global repair & service sites to create, develop, implement, and maintain global quality standards and processes.
- Ensure interdependencies of FDA design controls, change controls, and production and process controls are met to develop processes with the right level of control and maturity.
- Gain a deep understanding of our system and leverage this knowledge to drive continuous improvement.
- Develop and implement innovative solutions to enhance quality outcomes.
- Develop and monitor process performance metrics, perform analysis, and act upon trends with minimal guidance.
Requirements
- Bachelor's degree in an engineering discipline required, with a Master's degree 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 generating technical reports and presenting to management.
- Proven project management skills with a results-oriented approach and strong problem-solving capabilities.
- Experience working in matrixed structures and global teams, with a track record of leading continuous process improvements.
- Fluent in English; highly organized, flexible, and skilled at prioritizing and multitasking.
What We Offer
- Flexible working hours with remote work possible (up to 60%)
- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100% subsidized) or free parking space
- Company sport groups and an in-house company gym
- Employee Assistance Program to support your health, mental, and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our 'Buttje&Deern' partner
- Bike leasing
About Olympus
Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people's lives healthier, safer, and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety.
As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety.
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