Job Summary
A medical device consultancy company has an open position for a Remote Consulting Services Design Quality Engineer in Cleveland.
Must be able to:
- Lead remediation activities for risk management and the design history file
- Provide leadership to design teams in sampling plans
- Lead quality related problem solving and root cause analysis
Must meet the following requirements for consideration:
- 2-7 years of experience. in regulated Medical Device Quality Assurance environment
- Practical knowledge of FDA Quality System Regulations, ISO 13485 and European Medical Device Directive
- Practical knowledge of ISO 14971, and related standards
- Bachelor's Degree in Engineering or related field required
