Regulatory Affairs / Quality Assurance Еngineer
Are you excited about data? Do you think cloud adoption is changing the way people and companies do business? Do you like being involved in solving complex business problems by creating advanced and innovative technical solutions?
If yes — we’ve got a solution for you!
Join ABCloudz — a full-service company helping customers modernize legacy applications, create new solutions, and manage data, applications, and infrastructure anywhere. With close to 300 engineers and consultants in 4 countries, ABCloudz has expertise with modernizations to Azure, AWS, and GCP, BI, Advanced Analytics, AI, Big Data, IoT, Application Development, DevOps, and Managed Services. Taking care of data for customers to make sure it’s secure, available, consistent, and managed in a cost-effective manner with mitigated risks — this is in our DNA. So if you enjoy working with data and considering what’s your next career move, we’ll be thrilled to talk to you!
ABCloudz is looking for a Regulatory Affairs/Quality Assurance Еngineer who will ensure continual visibility over the development and in-built references of legal and regulatory enactments. Also, you’ll identify activities necessary to ensure compliance. Besides, the candidate will ensure that the product team establishes controls and/or completes necessary activities to provide compliance.
Further, at ABCloudz, the Regulatory Affairs/Quality Assurance Еngineer will conduct reviews to ensure knowledge and fulfillment of device licensing, surveillance and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.
Responsibilities
- Remain aware of new or updated regulations, standards, and other official enactments that may apply to the product.
- Provide detailed analysis and gap analyses for new or revised enactments, SOPs.
- Ensure compliance schemes associated with all regulatory compliance documents distributed during the development.
- Participate in cross-functional design review teams to review all product improvement Design Inputs and potential Defect Reports.
- Recognize potential impacts on health or device efficacy (Safety Issues), criticality assessment to ensure the application of reasonable and required Risk Management, Verification, and Validation.
Qualifications
- 1+ years of experience in a position responsible for medical device quality engineering duties.
- QA Engineer technical background
- Ability to manage multiple projects at once.
- Good communication skills.
- Excellent technical writing.
- At least the Upper-Intermediate English level.
Preferred skills
- Experience with quality systems regulations, ISO standards, information privacy and security, environmental controls.
- Expertise working in a regulated environment as a QA/BA.
- Practice working with medical device development.
Who we are?
ABCloudz is a global full-service company operating at the cutting edge of the latest application development and data management technologies. At ABCloudz, we believe optimal data environments are the greatest competitive advantage, and our Solutions Architects have experience with building enterprise-grade systems.
It is why our team has dedicated ourselves to helping hundreds of organizations – from start-ups to Fortune 100 companies – with architecting cloud solutions, developing web and mobile applications, optimizing complex data workloads, and managing workloads on an on-going basis — no matter where those datasets may reside.
Join an always-growing company to operate on the cutting-edge of information technologies, cloud services, application development, and digital infrastructure. At ABCloudz, we created a perfect environment to raise your professional skills, understand new technologies, and work with world-class companies.
Our expertise covers all major cloud and on-premises and databases, including Oracle, SQL Server, Azure, AWS, and GCP solutions. Our prolific developers are focused on delivering the best possible digital solutions leveraging our expertise with BI, Advanced Analytics, AI, Big Data, IoT, DevOps, and Managed Services.
Our mission is to help businesses accurately, efficiently, and reliably build, move, and manage data workloads. The trusted ABCloudz team now has hundreds of employees in five countries, including our headquarters in Redmond, Washington, and offices in San Francisco, Israel, Poland, and Ukraine.
Your dream job not found?
We always keep the doors open for outstanding talents. Want to work with us, but couldn't find an appropriate opening? Let us know about your passion, tell us why you stand out from the crowd and how you can make the difference working at ABCloudz. Just hit the button below to send us your resume.
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