Post Market Quality Specialist
4 weeks ago
Saluda Medical is a pioneering company in the field of closed-loop Spinal Cord Stimulation (SCS). As a Post-Market Quality Specialist, you will play a crucial role in ensuring the quality and compliance of our medical devices.
Key Responsibilities:
- Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback
- Manage complaint and feedback files, including timely intake and closure
- Support additional information requests, device returns, and Complaint Response Letters
- Provide data inputs and analysis as needed, including monthly metrics and regulatory agency requests
- Communicate professionally with external parties, including end users
- Maintain record retention and audit readiness processes
- Participate in broader Quality Management System (QMS) initiatives and projects
Requirements:
- Bachelor's degree in engineering, science, technology, or health
- 2+ years' experience in the medical device industry or similar regulated environment
- Strong attention to detail and knowledge of ISO 13485 Quality Management System
- Strong verbal communication and technical writing skills
- Individual contributor with organization and time management skills
- Strong aptitude for learning technical concepts
- Strong analytical and decision-making skills
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Post Market Quality Engineer
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Minneapolis, Minnesota, United States Saluda Medical Full timeJob Title: Post Market Quality EngineerSaluda Medical is a pioneering company in closed-loop Spinal Cord Stimulation (SCS), a groundbreaking therapy that measures the spinal cord's response to stimulation and adjusts therapy in real-time.The Post-Market Quality Engineer plays a crucial role in ensuring the safety and effectiveness of Saluda Medical devices....
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