Validation/Testing Analyst II - Katalyst Healthcares and Life Sciences : Job Details

Job description: The primary role of the Validation/Testing Analyst II is the timely and accurate execution of test procedures, recording the test data and writing a test report. This position offers an outstanding opportunity to improve your skills in product testing and quality assurance while working in a fast-paced, innovative environment. You will gain valuable experience in regulatory compliance and quality management systems, improving your professional development in the healthcare industry. Responsibilities:

• Preparation of test - set-up, adjustment and operation of equipment and device under test.
• Performance and verification of device testing / measurement activities per test plan, published standard, test protocol and/or SOP for each test.
• Working in the laboratory, performing testing of a device with elevated noise level.
• Recognition of problems and taking corrective actions.
• Recording test results in required form and writing test reports describing results and procedures used.
• Communication of test status and providing feedback on issues found within tests and tasks to Project Managers.
• Identification, recommendation and assistance with process / equipment improvements for set-ups and test methods. Writing and revising Test Protocols as requested.
• Documenting regular equipment checks to ensure functionality and maintain product integrity.
• Maintaining accurate product records for traceability, ensuring compliance with quality assurance standards.
• Supporting inventory supervision, proactively stocking materials, and fulfilling material requests to ensure smooth operations.
• Keeping training logs and SOP readership up to date. Provide training to other technicians for test procedures and methods as required.
• Ensuring the lab remains clean, organized and reporting any safety concerns to the Lab Manager.
• Following all environmental and safety instructions, including wearing PPE when applicable.
• Identification of possible hazardous situations and reporting them to the Project Managers.
• Support Project Managers with compiling raw data of test results in required form.
• Management of multiple projects/tests at any one time ensuring all commitments are met.
• Other duties as assigned.

Requirements:

• Minimum High School Diploma/GED; preferred associate's degree and/or equivalent work experience.
• Prior Experience: 3-5 years of testing of electro-mechanical with Software medical devices.
• Prior experience and/or knowledge of acoustic systems is preferable.
• Background in data analysis is preferable.
• Microsoft Office, computer literate.
• Experience testing activities of electro-mechanical / software medical devices.
• Background in acoustics.
• Experience executing and writing test protocols.
• Experience in data analysis (bonus).
• Experience or knowledge of Acoustic systems (bonus).