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Specialized QMS architect role for regulated medical-device employer in Pune reduces general applicant competition.
Role requires regulated QMS and validation expertise, making cross-industry transferability limited.
Explicit 8+ years requirement and domain-specific QMS, regulatory, and validation expectations make filters strict.
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Design and implement technical solutions for Quality Management Systems (QMS) to meet business requirements across a global organization.
Oversee all technical delivery and act as a backup technical owner for QMS platforms, including managing platform roadmaps and handling IT security vulnerabilities within SLAs.
Partner with business leaders to assess implementation complexity, minimize unnecessary customization, and manage support transition from Level 2 to Level 3 within the transformation team.
Bachelor’s degree.
8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems (preferably ETQ, IQVIA, Force.com platform).
Experience working with regulated environments and regulatory compliance in pharmaceutical/medical device settings preferred but not mandatory.
Work Experience Required: 8+ years relevant experience.
Experience working with 21 CFR part 820 and validation deliverables (IQ/OQ/SDD) within the software development life cycle for regulated applications.
Strong technical background in server-client/web architecture, API integrations, server administration, SQL, and relational databases.
Experience collaborating with application vendors and 3rd party consultants in a global, matrixed IT environment with ability to communicate effectively with senior leadership.