Lenora Systems Plano , TX 75023
Position #1 Plano, TX:
Proficient in requirement analysis, test case design, test protocol development.
Good Documentation Practice
Verification & Validation Process
Test Protocol & Report writing
Various Testing process
Good technical writing skills
Must have experience in Medical Devices with Product Verification, Software verification and IEC 62304.
Position #2 Dallas, TX:
Must have experience on verification of any medical device applications and device such as Insulin pumps, BG meter etc.
Strong Experience on Manual Testing which includes Testing Life Cycle Models, development of Test Cases, Execution of Test Cases, Defect Tracking, Report Preparation etc.
Working knowledge of FDA regulations, QSR, ISO 13485, 21 CFR Part 820, Part 11 compliance.
Preferred to have knowledge/Experience on DFMEA, PFMEA, Executing and Writing IQ/OQ/PQ
Experience in 21 CFR 820 -Quality System Regulation, ISO 13485 Medical Devices- Quality management systems-Requirements for regulatory purposes also ISO 14971 requirements.