IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Application Architect, IT Quality Management Systems

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 4, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Application Architect, IT Quality Management Systems USA - California - Irvine 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. E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 30+ Days Ago Full time Req-3086 About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Application Architect, IT Quality Management Systems, Executive , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Licensed Medicare Insurance Agent - State of the Art Lead Management Platform
Description: Considered the gold rush of insurance, Assurance, a Prudential company, is actively looking for independent health insurance agents WITH AHIP certification Residential Insurance License required to (more...)
Company: ASSURANCE Independent Agents
Location: Cypress
Posted on: 04/12/2021

Assistant Salon Manager - Smoke Tree Village
Description: Assistant Salon Manager Got shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let--s talk Maybe you--re a stylist who wants more
Company: Great Clips
Location: Cathedral City
Posted on: 04/12/2021

Shift Manager
Description: Description br br Working at Pizza Hut-- is about making hungry people happy. It's about being independent and having fun, making new friends and earning extra cash. If you're ready to take the next (more...)
Company: Pizza Hut
Location: Arcadia
Posted on: 04/12/2021


Ecommerce Marketing Manager
Description: Looking for Highly Motivated Digital Marketing Manager br Company Description br Our company is a leading distributors of PC and Consumer Electronic accessories based in City of Industry, Ca. which (more...)
Company: Go Direct Inc.
Location: Rowland Heights
Posted on: 04/12/2021

Area Business Development Director - NW Houston, TX
Description: Job Description - Area Business Development Director - NW Houston, TX 2116031 Job Description Area Business Development Director - NW Houston, TX 2116031 Description Encompass Health Rehabilitation (more...)
Company: CTI Education Group
Location: Cypress
Posted on: 04/12/2021

Service Manager 2 - Santee, Ca
Description: Job DescriptionImportant Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application for (more...)
Company: Wells Fargo
Location: Santee
Posted on: 04/12/2021

Licensed Medicare Insurance Agent - State of the Art Lead Management Platform
Description: Considered the gold rush of insurance, Assurance, a Prudential company, is actively looking for independent health insurance agents WITH AHIP certification Residential Insurance License required to (more...)
Company: ASSURANCE Independent Agents
Location: Hacienda Heights
Posted on: 04/12/2021

Licensed Medicare Insurance Agent - State of the Art Lead Management Platform
Description: Considered the gold rush of insurance, Assurance, a Prudential company, is actively looking for independent health insurance agents WITH AHIP certification Residential Insurance License required to (more...)
Company: ASSURANCE Independent Agents
Location: Fountain Valley
Posted on: 04/12/2021

Shift Manager
Description: Description br br Working at Pizza Hut-- is about making hungry people happy. It's about being independent and having fun, making new friends and earning extra cash. If you're ready to take the next (more...)
Company: Pizza Hut
Location: Altadena
Posted on: 04/12/2021

Licensed Medicare Insurance Agent - State of the Art Lead Management Platform
Description: Considered the gold rush of insurance, Assurance, a Prudential company, is actively looking for independent health insurance agents WITH AHIP certification Residential Insurance License required to (more...)
Company: ASSURANCE Independent Agents
Location: Coachella
Posted on: 04/12/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds