3 - 13 years
3 - 12 Lacs
Posted:1 day ago|
Platform:
On-site
Full Time
Key Deliverables: Provide quality oversight across design, validation, and lifecycle of combination products Support regulatory submissions, audits, and RTQ responses Ensure compliance with global standards including ISO 13485 and 21 CFR Lead quality process improvements for device, labeling, and packaging Role Responsibilities: Act as single point of quality contact for final product activities Review risk management, HFE documentation, and design controls Train teams on quality and regulatory requirements for combination products Manage complaint investigations and site transfer quality activities
Amgen Technology Private Limited
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