Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of ground-breaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
The Supplier Quality Engineer provides quality engineering expertise and works closely with suppliers to ensure that the product or service received meets requirements and specifications.
This is a hybrid role where you will be required to work 3 days on-site per week.
How you'll make an impact:
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Investigate and develop action plans for complex manufacturing product quality and compliance issues (e.g., SCAR management, non-conformances, productivity, and audit observations) for all supplier processes based on engineering principles and Edwards quality standards.
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Own and coordinate supplier Notice of Change (NOC) requests. Manage supplier project plans, facilitate part qualification process, and ensure closure of any change plan deliverables.
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Monitor supplier performance and develop improvement plans to mitigate risk and supply chain disruptions. Activities include supporting Supplier Business Reviews, Scorecard management, Critical Control Point monitoring, and overall quality performance assessment.
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Update, and maintain supplier file content including Supplier Management system administration, support Approved Supplier List (ASL) activities, and any required Preference Category status changes.
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Partner with Supplier Management to onboard new suppliers in alignment with each category strategy. Activities include developing and finalizing Quality Agreements, supporting Technical Assessment, Supplier Management system administration (SQMS), and conducting the initial qualification audits.
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Support the Quality Audit program for all identified suppliers (Surveillance, Qualification, Performance). Supplier Quality Engineers will conduct the Quality Audit, drive corrective actions, and ensure closure of any findings.
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Support Edwards sites in their Receive on Certification program owning supplier agreements, SPC data reviews, and process audits, where appropriate.
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Train, coach, and guide lower level employees on routine procedures
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Other incidental duties assigned by Leadership
What you'll need (Required):
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Minimum Bachelor's Hons Degree in Engineering or Scientific field and minimum 4 years work experience Required
What else we look for (Preferred):
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Proven expertise in usage of MS Office Suite
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Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
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Working knowledge and understanding of statistical techniques
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Lead Auditor experience desirable
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Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
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Strong problem-solving, organizational, analytical and critical thinking skills
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Substantial understanding of processes and equipment used in assigned work
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Good leadership skills and ability to influence change
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Knowledge of and adherence to Quality systems
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Strict attention to detail
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Ability to interact professionally with all organizational levels
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Ability to manage competing priorities in a fast paced environment
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Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
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Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.
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