Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA 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/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Responsibilities and duties
- Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.
- Conduct design reviews & risk management reviews as required during various project phases.
- Work with R&D during Electrical/ Embedded developments (Electrical & electronic hardware development and Software development) to provide inputs w.r.t quality & safety.
- Participate and conduct DHF / DMR Reviews for Software / Electrical/ Embedded developments.
- Support Computer System Validations & Process Validation as required.
- Support in conducting cybersecurity risk assessment documents.
- Support in V&V to ensure product compliance, safety, reliability & effectiveness.
- Review of Clinical Evaluation Reports, Post Market Clinical Follow up & Safety documentation and Regulatory documentation on Quality aspect.
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Experience/skills required.
- Practical implementation of Risk Management of Medical Device per ISO 14971.
- Experience with Risk Analysis tools and techniques.
- Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.
- Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).
- Understanding of various documentation required during Hardware & Software development lifecycle.
- Understanding of electrical & embedded component's working principle and functionality.
- Familiarity with IEC 60601-1 family of standards.
- Familiarity with any basic programming language, embedded software & tools.
- Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).
Education
- B. Tech / B.E / M. Tech / M.S. - Software/ Electrical/ Embedded Engineering
- Experience: 4-8 years
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.