Architect, IT Solutions(QMS)

Posted 11 Days Ago
Be an Early Applicant
Pune, Mahārāshtra, IND
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
Designs, implements, and oversees enterprise Quality Management System solutions globally. Owns technical delivery, application standards, platform roadmaps, security remediation, technical debt reduction, system integrity, integrations, validation, and support processes. Partners with business leaders and vendors to assess initiatives, manage implementations, and deliver scalable solutions in regulated pharmaceutical and medical device environments.
Summary Generated by Built In

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 as a key technical contributor for our enterprise quality management systems reporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Application Architect, QMS, you will be a key member of a global quality technical transformation team implementing and guiding the technical evolution and optimization of our QMS platforms across a global organization.  

How will you make an impact:

  • Design and implement QMS technical solutions to meet business requirements.  
  • Oversee all technical delivery for QMS and backup the technical owner of the system(s) 
  • Define and implement IT application standards, ensuring alignment with global IT and industry best practices for software development and system implementation. 
  • Contribute and help manage the 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 for application integrity, making informed recommendations to minimize unnecessary customization and preserve system purpose. 
  • Execute a 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 with 8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems with a preference for experience with ETQ, IQVIA and the Force.com platform. 

What else we look for (Preferred):

  • Experience working with 21 CFR part 820 
  • Experience working in a regulated environment, and strong understanding of concepts 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 in server-client and/or web hosted application architecture and integrations via API’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 3rd party 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 mindset with an excitement to learn new technologies.  
  • Have a passion for our mission at Edwards Lifesciences.  

Recruiting scam alert: Read our notice about potential recruiting scams.

Skills Required

  • Bachelor's degree
  • 8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems
  • Experience with ETQ, IQVIA, and the Force.com platform
  • Experience working with 21 CFR Part 820
  • Experience in a regulated pharmaceutical or medical device environment
  • Experience with commercial off-the-shelf applications and master data structures
  • Experience writing and executing validation deliverables such as IQ, OQ, and SDD in an SDLC
  • Experience with server-client or web-hosted application architecture and API integrations
  • Experience with server administration supporting enterprise applications
  • Experience with SQL and relational databases
  • Experience working with application vendors and third-party consulting companies
  • Ability to communicate and present recommendations to senior leadership
  • Experience working in a global, highly matrixed, team-oriented IT environment

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

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. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

Similar Jobs

Capco Logo Capco

FSA Business Architecture - Regulatory Reporting

Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Remote or Hybrid
India
6000 Employees

Capco Logo Capco

IFRS BA

Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Remote or Hybrid
India
6000 Employees

Zocdoc Logo Zocdoc

Senior Associate, Compliance

Healthtech • Information Technology • Software • Telehealth
Easy Apply
Hybrid
Pune, Mahārāshtra, IND
900 Employees

Ericsson Logo Ericsson

Solution Integrator

Cloud • Information Technology • Internet of Things • Machine Learning • Software • Cybersecurity • Infrastructure as a Service (IaaS)
In-Office
Pune, Mahārāshtra, IND
88000 Employees

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account