R&D Quality Assurance Technician

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Summary:
The main function of a technician is to set-up and execute feasibility studies, experiments, and tests following established protocols - to develop findings for the validation and improvement of packaging and manufacturing processes/methods based on engineering principles; and develop reports for Engineering review. Operate a variety of equipment for product Distribution & Shelf-life simulation and sterile barrier Integrity testing.

Education and Experience:
• H.S. Diploma or equivalent
• 0-2 years of experience required

Responsibilities:
• Build prototypes and prepare feasibility test units, samples, and/or chemical solutions
• Support engineering activities such as test, modification, fabrication, and assembly under the close supervision of Engineers.
• Perform work using drawings, diagrams, written and verbal instructions to perform testing, and trouble-shooting functions
• Operate basic lab equipment and perform routine testing.
• Collect and document test data.
• Manage own projects on-time, and assist teammates with their projects as required.

Additional Skills:
• Good computer skills, including experience with MS Office Suite
• Ability to read, comprehend, write and speak English, and good communication skills required
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Strict attention to detail
• Aptitude for high achievement in both quality and productivity
• Ability to provide feedback in a professional, direct, and tactful manner
• Must be able to work in a team environment and with limited supervision
• Proven success adhering to project schedules and managing small projects
• Knowledge of validation and improvement of automated equipment is a plus
• Ability to troubleshoot manufacturing equipment is a plus
• Ability to lift / handle packages up to 20 lbs.