Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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).