Senior Quality Engineer (m/f/d) Medtech Global Repair & Services

at  Olympus Europa SE Co KG OEKG

Your responsibilities

• Provide input and 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 transitioning from legal manufacturer across multiple repair sites and quality systems.
• Lead, support, and guide the repair sites (as needed) to address quality issues and resolution using the best quality techniques and principles.
• Lead and collaborate with global repair & service sites to create, develop, implement and maintain global quality standards and processes.
• Understand the interdependencies of FDA design controls, change controls and production and process controls to ensure processes are developed with the right level of control and maturity for repair and service sites.
• Gain a deep understanding of how the system supports various processes within the repair & service quality organization 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.

Your qualification

• 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.
• 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.
• Willingness to travel internationally and domestically up to 15%, with availability to work across global time zones.

Your benefits

• Flexible working hours, 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 inhouse 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

Further information:

• Provide input and 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 transitioning from legal manufacturer across multiple repair sites and quality systems.
• Lead, support, and guide the repair sites (as needed) to address quality issues and resolution using the best quality techniques and principles.
• Lead and collaborate with global repair & service sites to create, develop, implement and maintain global quality standards and processes.
• Understand the interdependencies of FDA design controls, change controls and production and process controls to ensure processes are developed with the right level of control and maturity for repair and service sites.
• Gain a deep understanding of how the system supports various processes within the repair & service quality organization 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