Quality Engineer
Year Bangalore, Karnataka, India
Job Description
Responsible for:
- Analyzing, collecting data, and providing accurate, documented information about 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
- 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
- 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
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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Job Detail
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Job IdJD2930054
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBangalore, Karnataka, India
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EducationNot mentioned
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ExperienceYear