Urgent Job Opening As a Quality Engineer

18 hours ago

Pune, Maharashtra, India Prajakta Jobs Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per year


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 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


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