Description
Required skills:- BS in Software Engineering or related field
- 3-4 years of medical device SQE experience
- Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- Skilled in test plan development and root cause failure analysis.
- ASQ CQE, CRE, CSQE certification desirable, but not essential
This is an urgent role. If interested, please apply ASAP and I will reach out to you promptly to schedule a time to speak.