Job title: Staff Engineer
Job description: Are you interested in working for a global company where you can work across functions and on awide-varietyof projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunit
Are you interested in working for a global company where you can work across functions and on awide-varietyof projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World’s Best Workplaces, apply now! Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team:https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team Who We Want Dedicated achievers . People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Analytical problem solvers . People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevents future issue Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. What You Will Do .1Roles and Responsibilities Primarily responsible for: Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER. Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product. Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted. Participate in design reviews during various phases of NPD. Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness. Expert-level knowledge of current industry standards for New Product Development and risk management practices. Solutions-based approach to quality engineering, wants to provide “added value” (“quality police” attitudes won’t survive in our culture). Exposure to any Programming language & on Software Testing concepts. Design And User Validation exposure. Good interpersonal and communication skills. What You Need Education: B.Tech/BE in Computer/ IT/ Electronics Engineering Experience: 9-11 years Personality: Demonstrated organizational and written/verbal communication skills. Demonstrated ability to self-motivate Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Demonstrated ability to prioritize tasks in a deadline-driven environment. Specific Job Skills: Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820) AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective. Experience on NPD process and various phases of new product development. Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards. Design and User Validation. Participant and/or champion for Corrective Action and Preventative Action (CAPA) process. Knowledge of IEC 62304 standard for Medical device software. Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches. Educate the organization in exceptional engineering processes & practices including good documentation, formal design reviews and the other practices mentioned above. Based at Division: SGTC Based at Location: Gurgaon Know someone at Stryker? Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat About Stryker Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting
Location: Gurgaon, Haryana
Job date: Fri, 21 Jan 2022 23:35:45 GMT
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