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Who we want: Strykeris hiring aSeniorDesign Quality Engineerfor our Design Quality Digital group for Stryker T&E digital product portfolios (Trauma, Foot & Ankle, Upper Extremities). The positionleadsthe quality activities to supportthenewproduct development(NPI)teams to ensure time-to-market, customer requirements, and technologyobjectivesare met while ensuring compliancetoglobal 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 ...