Quality Engineer
Job Description:
Responsible for: . Analyzing, collecting data, and providing accurate, documented information abou
t the status of quality . Verifying the correctness of quality related development results in compliance
with the Quality Management Plan & authorize their release for medical devices . Validation of compliance to basic requirements, e.g. ISO standards and
regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA) . Assessment of completeness of Design history
file and Device master records . Participate in reviews as per QMS, external and internal audits Experienced in: . Product risk management & non-product software
validation processes for medical devices . Creation and maintenance of technical file/summary technical documentation (STED) . Medical device development (including
SW) and Software engineering best practices . Agile methods / TIR45 Knowledge on: . Compliant to ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304
, MDR, QSR within projects . Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001) . Non-regulated software like Apps for
Apple / Android healthcare software development environment will be an added advantage Excellent oral and written
communication skills Good to have certifications on ISO standards Experience : 7-8 Years Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited Experience Level: Experienced Professional Full / Part time: Full-time
Key Skills :
Company Profile
employs engineers to help you plan and design an
effective construction strategy. Use design software to plan and design structures
in line with industry and government standards. Involves
pre-construction logistics to some extent.
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