Sr Quality Engineer

Amgen · Hyderabad, India

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QualityFull-timeCompany career page

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Role summary

This senior quality engineering position in Hyderabad involves providing quality oversight for combination and non-combination products throughout development and commercialization. Responsibilities include managing design controls, risk assessments, regulatory submissions, and lifecycle activities such as complaint investigations and manufacturing site transfers. The role requires a degree in science with 4–12 years of quality experience, depending on educational level, ideally including pharmaceutical or biotech device expertise.

What they're looking for

Bachelor's degree in science field with 6-8 years quality experience, or master's degree with 4-6 years, or doctorate
5+ years quality and manufacturing experience in biotech or pharmaceutical industry
Knowledge of device design control, change control, risk management, and human factors engineering
Familiarity with regulations and standards including MDR, ISO 13485, ICH Q8/Q9/Q10, and 21 CFR 820/211
Ability to manage multiple medium-complexity projects simultaneously
Experience with combination product launches and quality management systems
Willingness to travel 15-20% domestically and internationally

What you'll be doing

Provide quality technical expertise and oversight for combination and non-combination product development
Ensure alignment of design plans, risk management documentation, and control plans across programs
Review and oversee human factors engineering protocols and audit HFE suppliers
Contribute to regulatory submissions and support audits and inspections throughout product lifecycle
Lead continuous improvements to quality processes for devices, assembly, labeling, and packaging

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Date posted30 days ago

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