Senior Design Quality Engineer - Medical Device Software
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Stryker India Private Limited
📍 gurgaon/gurugram, gurgaon district, India
Job Description
Senior Engineer, Digital Quality Work Flexibility: Hybrid Who we want: Stryker is hiring a Senior Design Quality Engineer for our Design Quality Digital group for Stryker T&E digital product portfolios (Trauma, Foot & Ankle, Upper Extremities). The position leads the quality activities to support the new product development (NPI) teams to ensure time-to-market, customer requirements, and technology objectives are met while ensuring compliance to global quality and regulatory requirements. What you will do: Primarily responsible for Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Test log test plans, Software verification and Validation, Product Security documents review. Owns Risk Management per ISO14971 to ensure the safety and effectiveness of product. Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted. DQA shall drive coordination with different departments (s...