Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
How you’ll make an impact:
• Supervise a team of QS related roles coordinators/associate and oversee the daily activities, including establishing schedules, organizing and overseeing the execution of complex change efforts, ensuring staff is appropriately trained to perform assigned work, and provide guidance and coaching
• Lead in the evaluation of current and new processes, the identification of opportunities and the implementation of solutions to improve the efficiency of processes within and between related functional areas. Identify technical and/or process problems to determine the root cause, propose recommendations and develop improvement strategies to fill the skills/competence gaps
• Act as a liaison between corporate team and people for unresolved issues. Work with global team to have common approach to compliance management and lead improvement initiatives across functional/global boundaries for QS related roles
• Ensure compliance with internal procedures, and implemented change control process continuously meet EW Quality System in compliance with regulatory requirements
• SME for Quality Systems. Provide training to employees across functions to ensure appropriate understanding and deployment of the system. Provide multifunctional guidance to the user to facilitate the performance of their required training
• Review and analyze performance metrics. Share trend metrics with management
• Other incidental duties assigned by Leadership
What you'll need (Required):
•Bachelor's Degree in Engineering or related field
• 4 years experience of experience using a document product life cycle management system required
• Previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering required
What else we look for (Preferred):
• Proven project management expertise
• Experience working in a medical device industry preferred
• Proven expertise in both Microsoft Office Suite, Enterprise Resource Planning (ERP) system, preferably JDE
• Excellent written and verbal communication, and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, as well as mediating and negotiating the needs of other areas to achieve consensus
• Solid understanding of medical device documentation development activities
• Full understanding of quality procedures while applying acquired expertise to analyze and solve problems without clear precedent
• Demonstrated ability to supervise teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee of employee
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Ability to interact professionally with all organizational levels
• Must be able to work with cross-functional teams as well as with colleagues from other departments within assigned area
• Complete understanding and wide application of principles, theories, and concepts in business area
• Ability to develop creative solutions to challenging problems; adept and experienced problem solver who is capable to determine root cause of technical issues and implements effective solutions in a timely manner
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
