.Senior Quality Engineer Olympus Medical Products Portugal (OMPP) | Medical SystemsOlympus Medical Products Portugal is a subsidiary of the Olympus Group. Its core business is the repair of optical and digital equipment of the brand, offering to Olympus customers repair services that meet the highest demands in terms of speed, approachability, reliability, and consistency. Your responsibilities As a Senior Quality Engineer within our newly established global service & repair quality organization, you will operate from a global perspective, ensuring consistency and excellence across all regions and facilities. Your mission-critical responsibilities will include: 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. Leverage this knowledge to drive continuous improvement. Develop and implement innovative solutions to enhance quality outcomes. Develop, monitor process performance metrics, perform analysis and act upon trends with minimal guidance. In this role, you will play a pivotal part in transforming our service and repair quality landscape, ensuring we meet and exceed our commitment to excellence. Minimum Qualifications EDUCATION: Bachelor's degree in an engineering discipline (Master's preferred). EXPERIENCE: 5+ years related experience, preferably in the medical device industry related to operations/design/quality engineering. Comprehensive background and knowledge with U.S. FDA QSR, requirements including ISO 13485, MDD and EU MDR, ISO 14971. Key Competencies Patient Safety Focus: You prioritize patient safety in every aspect of your work, ensuring that all medical products meet stringent quality standards. Strong Communication Skills: Effectively convey complex ideas through technical reports and presentations, inspiring those around you. Project Management Expertise: Lead projects from inception to completion, delivering consistent and impressive results
