Quality Engineer I - Añasco

The Quality Engineer will support EU MDR pFMEA remediation of products at one of our principal clients in Añasco, PR. The pFMEA remediation is required to be in compliance with ISO14971 that is part of the EU MDR requirements. The incumbent will work in pFMEA and Risk Management documentation to transfer to latest GSOP-504 templates and ensure the documentation is following ISO 14971. Work with project teams to calculate p1 values based on technical documentation and includes rationale to statistically support results. Review and approve validations and completion reports for existing products, processes, and equipment as a result of EU MDR effort. Support statistical analysis of the data to support the reports. Interact and coordinate activities with other departments, external vendors, and customers.
Requisitos:
Bachelor's Degree in Engineering or Science. Certified Quality Engineer (CQE), preferred. 3 to 5 years of experience in an FDA regulated environment. Experience in Risk Management documentation and in in ISO 14971/EU MDR regulation, preferred. Demonstrates excellent knowledge of statistical sampling and analysis, including DOE design. Demonstrates excellent organizational and communication skills and proficiency with MS Word and Excel and statistical software. Fully Bilingual. Professional Services Contract 1362