Let’s do this. Let’s change the world. In this vital role you will act as the
Quality Engineering representative on multi-functional teams, employ quality
principles and company’s procedures including but not limited to the areas of
device design control, Change Control and NC/CAPA, Risk Management, Human
Factors Engineering, to ensure development and lifecycle management of final
product align with dynamic global regulations and standards.
The Sr Quality Engineer will be an integral part of the design and development
of combination products, providing quality oversight of the processes and
deliverables generated throughout development and commercialization. In
addition, this role will also support various aspects of the product lifecycle
including complaint investigations, expansion and transfer of products to recent
manufacturing sites, inspection readiness activities, and platform support and
improvements.
RESPONSIBILITIES:
* Provide Quality technical expertise, Quality oversight, and serve as a single
point of Quality contact for combination and non-combination products
associated with final product activities.
* Ensure program alignment and proper linkages within the Design and
Development Plans, Risk Management Documentation, and Control Plans. Provide
oversight and review of Human Factors Engineering (HFE) Protocols and
Reports, as well as onboarding and auditing HFE suppliers related to life
cycle management of commercial programs.
* Train and educate key functional partners and management on combination
product requirements, standards and regulations
* Contribute to content and review of regulatory submissions and RTQs, and
support audits and inspections for associated projects related to life cycle
management of final product programs
* Scope may include a wide range of products, including but not limited to
vial, prefilled syringes, needle protection systems, fluid transfer devices,
pen injectors, automatic p
📌 Sr Quality Engineer (Hyderabad)
🏢 AMGEN
📍 Hyderabad
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