Quality Specialist - Software Medical Devices
Location
Bangalore | India
Job description
Requirements
Skill & Competency Requirements:
- Bachelor’s degree in Computer Engineering, Electronics, Electrical Engineering or similar field
- Minimum of 5 years of relevant work experience in software engineering or quality engineering in medical device development
- Looking for work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)
o Quality Management System – ISO 13485
o SiMD – IEC 62304
o SaMD – IEC 82304
o FDA 21 CFR 820.30
o 2017/745 – European Union Medical Device Regulation (EU MDR)
o General Principles of Software Validation
o FDA CFR Part 11 Compliance
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Technical writing ability – clear and concise writing easily understood by multiple audiences (auditors, peers, etc.)
Job tags
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