Edwards Lifesciences IT BSA, Quality Assurance in Irvine, California
Edwards Lifesciences is hiring for an Information Technology Business Systems Analyst (BSA) to support our enterprise quality systems. In this role you will have accountability for systems administration and technical support of Edwards Lifesciences’ global quality and compliance applications and infrastructure. Additionally, you will implement and optimize small to mid-sized solutions that improve system adoptions, functionality, process efficiencies, and effectiveness. The BSA serves as a domain expert of quality technologies, applications, and solutions to improve business processes. Qualified candidates will have experience with Reliance EtQ, Pilgrim Software SmartSolve, or equivalent QMS applications. Additionally, qualified candidates will have programming experience such as SQL and Python. Responsibilities:
Provide operational support, in the form of, system administration/configuration and subject matter expertise to ensure quality management systems operate efficiently
Serve as liaison between business process owners in Business Units, Functional
Groups, Regions, and IT
Keep current with quality management technologies in support of business process and recommend technologies that will increase overall effectiveness
Document and develop detailed diagrams of applications and interfaces used to support business processes
Lead and/or manage small to mid-sized projects / enhancements to reengineer and optimize business processes and systems
Configure and test systems to execute features, integration, and reporting per Software Development Lifecycle (SDLC)
Familiarity with validated IT systems, with the ability to write requirement documents, specification documents, and test scripts leading to the execution of validation plans
Work with stakeholders in developing ROI based business cases for enhancements and small to mid-sized projects
Required Education, Experience, & Skills:
A Bachelor’s degree in computer science, business, technology or related field is required
Master's degree in computer science, business, technology or related field is preferred
Must have a minimum 4 years of experience in a Business Systems Analyst role with a bachelor’s degree; a minimum of 2 years of experience in a Business Systems Analyst role is required with a master’s degree
Must have experience with Quality Management System applications. Reliance EtQ and Pilgrim Software SmartSolve applications are a plus.
Must have 1 to 2 years of programming experience. SQL and Python programming languages are a plus
Strong analytical and logical problem-solving skills
Strong interpersonal, written, and verbal communication skills
Organizational and project management skills
Possess and display sound judgment, initiative, flexibility, and detail-orientation
Ability to develop and maintain business and technical documentation
Competent in handling multiple tasks with attention to detail, and perform duties with minimal supervision
Ability to adapt to new technologies
Ability to adapt to rapidly changing environment
Demonstrates creativity to develop and implement innovative solutions and changes
Invests time in self-development/improvement, e.g., higher education, participation in developing and implementing solutions in areas outside of normal responsibilities, etc.
Ability to assist with mapping, troubleshooting, and optimizing interfaces for multiple systems
Experience working in complex, matrixed environments
Experience working in a complex global business environment
Experience managing small to mid-sized IT projects
Knowledge of Good Quality/Good Documentation Practices (GxP) processes
Knowledge of FDA guidelines for Software Quality, Systems Validation, and System Development Lifecycle
Moderate understanding and knowledge of quality information systems, supporting quality processes, such as Non-Conformance, Complaints, Corrective and Preventative Actions (CAPA), etc.
Experience with identifying, integrating, and managing Software as a Service (SaaS) solutions and external vendors
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.