Senior Quality Engineer (Global) Olympus Medical Products Portugal (OMPP) | Medical Systems
Olympus 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 Skills 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. Collaborative Spirit: Seamlessly work with global teams, fostering an environment where ideas thrive and success is shared. Critical Thinking: Analyze situations deeply to make informed decisions that consider all aspects of a problem. Results-Oriented: Driven to achieve goals and meet high performance standards, focusing on impactful outcomes. Empathetic Approach: Understand and appreciate diverse perspectives, promoting an inclusive and supportive workplace. Attention to Detail: Ensure accuracy and excellence in every task with a meticulous approach. We also value adaptability, strategic thinking, and the ability to build trust and motivate others. If these qualities resonate with you, we invite you to join our team and make a meaningful impact!
Compensation and Benefits Competitive Salary: Receive a salary that not only reflects your skills and experience but also competes favorably in the market. Stable Employment: Enjoy the security of a permanent employment contract, providing stability in your career journey with us. Comprehensive Health Insurance: Individual health insurance and reduced pricing for family members, ensuring your peace of mind. Vacation Policy: Enjoy 24 vacation days, with additional days off for your birthday and December 24th, promoting a healthy work-life balance. Flexible Work Model: The possibility of a hybrid work model, adaptable according to your role, balancing between home and office to fit your lifestyle. Nutritional Options at Work: A canteen with diverse meal choices including meat, fish, diet, vegetarian, and composed salads. Unlimited Access to LinkedIn Learning: Enhance your skills and knowledge at your pace. Tailored Training: Initial and continuous training aligned with your career goals. Referral Program: Receive a financial reward for helping us find new colleagues. Engaging Events: Participate in team buildings, Christmas celebrations, and themed days. Online Wellness Classes: Access to Burnalong Olympus, with more than 40 available categories and over 1,000 instructors to choose from. Convenient Parking: Facilities for cars, motorcycles, and bikes, including electric car chargers, ensuring ease of commute. About Olympus Medical Systems The Medical Systems Division represents Olympus' largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.
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