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Software Product Quality Specialist
2 weeks ago
About the Role:
This Software Product Quality Specialist position involves working closely with cross-functional teams to ensure the quality and integrity of our software products. Your strong background in quality management systems, including ISO 13485 and ISO 14971, will enable you to develop and implement process and product verification and validation activities. Additionally, your experience in leading software products risk assessments and providing technical guidance and training will be valuable assets to our team.
Responsibilities:
- Develop and maintain quality standards for software products.
- Participate in new product development, design review, and design control activities.
- Develop and implement process and product verification and validation activities.
- Lead the activities associated with software products risk assessment.
- Provide technical guidance and training to other department members.
Requirements:
- Bachelor's degree in Engineering with a preference for Computer Science.
- At least 9 years of experience in medical device R&D quality engineering, systems, and/or quality engineering supporting R&D projects, design assurance, and documentation.
- Professional training and certification in quality management systems, including ISO 13485 and ISO 14971.
