Edwards Lifesciences

Develops transcatheter heart valves and devices

IT Application Architect - Quality Management Systems (QMS)

Enterprise ApplicationsConfirmed live in the last 24 hours

Full-timePune, Maharashtra, IndiaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree and 8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems are required.
Preferred experience includes ETQ, IQVIA, and the Force.com platform.
Experience working with 21 CFR Part 820 is preferred.
Experience working in a regulated environment and a strong understanding of concepts and regulatory compliance in pharmaceutical or medical device settings are preferred.
Experience with commercial off-the-shelf applications and a solid understanding of the role master data structure plays in a scalable enterprise solution are preferred.
Experience writing and executing validation deliverables, such as IQ/OQ/SDD, in the software development life cycle for validated, regulated applications is preferred.
A strong background in server-client and/or web-hosted application architecture and integrations via application programming interfaces is preferred.
Experience with server administration required to support an enterprise application is preferred.
Experience with structured query language and relational databases is preferred.
Experience working with application vendors and third-party consulting companies on technology implementations and delivery is preferred.
Comfort communicating and presenting ideas and recommendations to senior leadership is preferred.
Experience working in a global, highly matrixed, team-oriented IT environment is preferred.
A self-motivated, results-driven mindset and eagerness to learn new technologies are preferred.
Passion for Edwards Lifesciences' mission is preferred.

Responsibilities

Design and implement quality management system technical solutions to meet business requirements.
Oversee all technical delivery for quality management systems and back up the technical owner of the systems.
Define and implement IT application standards that align with global IT and industry best practices for software development and system implementation.
Contribute to and help manage technical platform roadmaps, including regular platform updates and prompt resolution of IT security vulnerabilities within established service-level agreements.
Advocate for technical debt remediation and continuous system improvements to drive business growth and development.
Partner with business leaders to understand organizational needs and assess implementation complexity for in-house and project-funded initiatives.
Steward application integrity by making informed recommendations to minimize unnecessary customization and preserve system purpose.
Execute a shift-left strategy for support and maintenance, transferring Level 2 support to the global team while retaining Level 3 support, problem management, and change management within the transformation team.

Edwards Lifesciences is expanding its global technology capabilities with the launch of a new IT Innovation Hub in Pune, India. The Hub strengthens the technology foundation that supports our business worldwide, working in close partnership with teams across regions to deliver reliable, high-quality solutions at scale.

Designed as a long-term investment, the Pune Hub will advance newer digital capabilities such as automation, data, AI, and cloud, and will include roles spanning end user services, application development, and enterprise platform teams.

Together, these teams will help Edwards operate more efficiently

and accelerate innovation in support of our mission of advancing patient care.

The IT Application Architect,Quality Management Systems (QMS),will serve asa key technical contributor for ourenterprisequality management systemsreporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Application Architect,QMS, you will be akey member of aglobal qualitytechnical transformation team implementing andguidingthetechnicalevolution and optimization ofour QMS platformsacrossa globalorganization.

How will you make an impact:

Design and implementQMStechnical solutions to meet business requirements.

Oversee all technical delivery forQMSandbackup thetechnicalownerof the system(s).

Define and implement ITapplicationstandards, ensuring alignment with global IT and industry best practices for software development and system implementation.

Contribute and help managethe technical platform roadmap(s), including regular platform updates and prompt resolution of IT security vulnerabilities within established SLAs.

Advocate for remediation of technical debt and continuous system improvements to drive business growth and development.

Partner with business leaders to understand organizational needs and assess implementation complexity for both in-house and project-funded initiatives.

Act as a steward forapplicationintegrity, making informed recommendations to minimize unnecessary customization and preserve system purpose.

Executea shift-left strategy for support and maintenance, transferring Level 2 (L2) support to the global team while retaining Level 3 (L3) support, problem management, and change management within the transformation team.

What you'll need (Required):

Bachelor’s degree with8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprisequality management systems with a preference for experience with ETQ,IQVIAand the Force.com platform.

What else we look for (Preferred):

Experience working with 21 CFR part820.

Experience working in a regulated environment, and strong understanding ofconcepts and regulatory compliance in a pharmaceutical/medical device setting.

Experience with commercial off the shelf applications and a solid understanding of the importance master data structure plays in a scalable enterprise solution.

Experience writing and executing validation deliverables (e.g.,IQ/OQ/SDD) in the software development life cycle (SDLC) for validated, regulated, applications.

Strong background inserver-client and/or web hostedapplicationarchitectureandintegrationsviaAPI’s.

Experience with server administration required to support an enterprise application.

Experience with structured query language (SQL)and relational databases.

Experience working with application vendors, and 3rdparty consulting companies on technology implementations and delivery.

Comfortable communicating and presenting ideas/recommendations to a senior leadership level.

Experience working in a global, highly matrixed, and team-oriented IT environment.

High energy, self-motivation, and results-driven mindsetwith an excitement to learn new technologies.

Have a passion for our mission at Edwards Lifesciences.

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About the Company

Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Company size: 10,001+
Company stage: IPO
Headquarters: Irvine, CA
Founded: 1958

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