Application Architect, IT Quality Management Systems

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

The Application Architect, IT Quality Management Systems has accountability for creating, designing, and supporting Edwards Lifesciences’ global quality and compliance applications and infrastructure.  Qualified candidates will have experience with enterprise functional design, architectural best practices, and implementation for Quality Management System solutions focused on a wide variety of functional areas such as Non-Conformance, Complaints, Corrective and Preventative Actions (CAPA), etc. Additionally, qualified candidates will have experience with Reliance EtQ, Pilgrim Software SmartSolve, or equivalent QMS applications.

In this role you will establish and maintain enterprise and/or domain level architecture through the stages of planning, design, execution, and operation. In doing so, you will develop and promulgate the standards and practices necessary to realize and sustain systems in accordance with established architectural plans and designs. Lastly, you will provide expert consultation to inform strategic technology and system decisions as well as tactical decisions related to projects.


Responsibilities:

  • Work on project teams to translate business requirements into system qualities that lead to repeatable and executable design strategies and patterns.
  • Identify and define the opportunities for integration, selecting the tools, specifying the shared data & code resources, defining the interfaces and data flows, and monitoring the success of the integration.
  • Develop, institute, and maintain the IT design methodology, development process methodology, technology standards, and best practices.
  • Provide oversight to ensure compliance with architectural standards and practices through all aspects of planning, execution, and operation.
  • Lead the evaluation of new technology targeted for possible integration into the existing IT environment.
  • Survey external emerging developments, and evangelize new technologies, standards and methodologies.
  • Develop, institute, and maintain the design and metadata repository for integrating all aspects of established architectural models.
  • Keep current with quality management technologies in support of business process and recommend technologies that will increase overall effectiveness.
  • Configure and test systems to execute features, integration, and reporting per Software Development Life Cycle (SDLC).
  • Work with stakeholders in developing ROI based business cases for enhancements and projects
  • Survey external emerging developments, and evangelize new technologies, standards and methodologies.
  • Develop, institute, and maintain the design and metadata repository for integrating all aspects of established architectural models.
  • General and administrative tasks.

Basic Qualifications:

  • Bachelor’s degree in Computer Science, Business, Technology or related field.
  • 10+ years of IT experience with increasing responsibility working with enterprise applications, within a global, matrixed organization.
  • 2+ years of demonstrably solid performance in an application architect role working with cross-functional teams (within IT and/or within the business) on enterprise-level or complex/novel system implementations.
  • 3+ years of FDA regulated industry experience (e.g. medical device, pharmaceuticals, etc.), or in a highly regulated environment such as the Aerospace or Automotive industry.
  • 3+ years of experience with Quality Management Systems such as Reliance EtQ and Pilgrim Software SmartSolve applications or equivalent QMS applications.
  • Familiarity with validated IT systems, with the ability to write requirement documents, specification documents, and test scripts leading to the execution of validation plans.
  • Broad and deep technical knowledge – expertise in multiple aspects including hardware, software, applications, and systems engineering and QA/testing
  • Knowledge of common architectural methodologies, frameworks, and patterns.
  • Expert in architectural modeling and documentation (e.g. UML, BPML).
  • Knowledge of Good Quality/Good Documentation Practices (GxP) processes.

Preferred Qualifications:

  • Master's degree in Computer Science, Business, Technology or related field.
  • TOGAF Certified
  • Strong analytical and logical problem-solving skills.
  • Creativity to develop and implement innovative solutions and changes.
  • 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.
  • Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.