Quality Engineer will provide Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).
Performing all testing activities for initiatives across one or more assigned projects, utilizing processes, methods, metrics and software that ensure the quality, reliability and systems safety and security.
Analyzing application/testing requirements, implement automation solutions for automated testing of applications/products. Designing, developing, maintaining and executing automated/manual test scripts.
This position will be responsible for developing and maintaining test cases, creating reusable test templates, create test data, conduct peer reviews, participate in test automation, analyze and thoroughly document defects detected during test execution.
Coordinate quality assessments by accrediting authorities, clients, and third party quality assessors. Coordinate the business units blind internal Proficiency Testing Program and evaluate Corrective Actions.
The tester is responsible for providing feedback on artifacts developed during requirements and analysis phase within client projects; authoring test cases/scripts; and performing test execution for both project and support related activities.
Identify and initiate research for any reported issues and perform root-cause analysis of any identified trends and issues; compile well-supported quality conclusions using quantitative and qualitative data analysis and results, and effectively communicate recommendations to key stakeholders.