Job Overview

Performs and supports all activities for Inspection Test and Measurement Equipment

(ITME) for the Cardiac Assist Disposables (CADI) business. Responsible for the control of all ITME and scheduling of calibration with vendors and ITME owners. Properly utilizes the tools and methods for calibration to ensure that all ITME is properly calibrated. Identifies out of tolerance (OOT) calibrations and provides support to OOT Investigators.

Job Responsibilities and Essential Duties

• Ensures scheduling of outside vendors in accordance with established calibration frequencies.
• Coordinates with site facilities Management and ITME owners to issue and control all scheduled calibrations to prevent use of out of calibration ITME assets
• Monitor calibration schedule to ensure necessary ITME equipment is properly calibrated in a timely manner.
• Ensure results of ITME calibrations are recorded using the designated calibration software.
• Investigation calibration results of ITME assets found out of tolerance (OOT) of its designated accuracy.
• Coordinate troubleshooting and repair of test equipment as required.
• This is not an inclusive list of job responsibilities.

Minimum Requirements

• A high school degree or equivalent required. An Associate’s degree and/or related certifications is preferred
• A minimum of two years of quality assurance experience with a working knowledge of calibration procedures and practices. two years of related experience in an FDA regulated industry is preferred. Medical device or pharmaceutical experience is ideal

Required Knowledge, Skills and Abilities

• Must have knowledge of metrology skills including a sound understanding dimensional tolerances and usage of precise mechanical measurement instruments.
• Must be able to read mechanical blueprints and electrical schematics, accurately apply scientific formulas, and read and maintain laboratory notebooks.
• Must demonstrate ability to be accurate and identify procedural inaccuracies and then make recommendations for improvements and effectively implement changes.
• Must demonstrate ability to work independently, make effective decisions, and resolve technical issues.
• Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization.
• Must demonstrate the ability to work effectively in teams to achieve results.
• Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.
• Must demonstrate ability to operate electronic measuring equipment, such as oscilloscopes, digital multi-meters, and generators.

#LI-AS1