Senior EOL Test Validation Engineer

Stryker · Gurugram, India

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QualityFull-timeCompany career page

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What they're looking for

Bachelor's degree in Mechanical, Electrical, Industrial, or Manufacturing Engineering
6+ years validation, manufacturing, or quality engineering in regulated industries
Hands-on execution of IQ/OQ/PQ protocols for equipment and manufacturing systems
Knowledge of GMP, FDA 21 CFR Part 820, ISO 13485, and risk management
Working knowledge of Computer System Validation methodologies and regulatory expectations
Experience reviewing test requirements and EOL tester qualification/validation

What you'll be doing

Support product and process introductions per Design Controls and Quality System requirements
Develop and maintain validation documentation including Plans, Protocols, and Final Reports
Lead IQ/OQ/PQ activities for manufacturing equipment, processes, tooling, and production systems
Collaborate with R&D, Manufacturing, Quality, Regulatory, and Operations on product industrialization
Ensure validation activities comply with GMP, FDA, ISO 13485, and internal standards

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Date posted4 days ago

Last source check1 day ago

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