Calibration Technician II

at  Nordson

JOB SUMMARY

The Equipment Calibration Coordinator will administer and maintain Calibration, Environmental Controls (coordination and reporting Admin.) and support on Equipment Maintenance records, ensuring all equipment and measurement tools are serviced in a timely manner in accordance with written procedures.

EDUCATION AND EXPERIENCE

• High school diploma required, minimum 3-years of BS Engineering degree is preferred, or equivalent (knowing GDT-geometric tolerances, metric and international measuring systems, units conversion, etc.).
• 2 years or more experience working in a GMP-medical device manufacturing or Lab environments.
• A minimum 40% English language skills (written and verbal) domination.
• Experience coordinating equipment assembly-disassembling activities (qualification, calibration, maintenance) is preferred, but not required.
• Working knowledge on measurement instruments.
• General knowledge of GMPs, GDPs, Quality Systems, FDA regulation, ISO 17025 and ISO 13485.

SKILLS AND ABILITIES

• Ability to work independently, prioritizing activities, organized with documents and scheduling attained, able to function in a fast-paced environment and able to effectively communicate and working with teams with an active participating role.
• Ability to interpreting drawings, measuring units and systems, or specifications.
• Fluent working knowledge of databases and administration (equipment management).
• Able to fluently preparing PowerPoint or XL tables or presentations over equipment, or plan status results.
• Ability to self-solving practical problems.
• High level of attention to detail.
• Computer Skills: knowledge in navigation and use of MS Windows operating system and networks.

• Primary Coordinator of equipment calibration activities and records housekeeping for the site.
• Setting up new and managing existing equipment serial or functional profiles in the eQMS (IFS), updating service status as necessary.
• Accurately filing up of reviewed and complete equipment calibration and logged in records
• Interacting with QA or Engineering, or external and third-party calibration and maintenance service providers, scheduling appointments, hosting on-site visits and presenting status during regulatory or customer audits.
• Supporting Maintenance with training or troubleshooting on Preventive Maintenance scheduling plans, and on calibration schedules for all required equipment in the facility.
• Promoting and preparing procedures for internal calibration, execution of calibration tasks in accordance with the established Calibration Procedure schedules and applicable regulations (i.e. ISO17025) to ensure all equipment requiring calibration is maintained within due dates.
• Responsible for the review and signing off of all calibration records to ensure requirements have been met.
• Assist in conducting equipment installation log into IFS, during qualification activities.
• Planning and coordinating with the calibration and environmental control external services to assure on time activities are accomplished accordingly, including the review and housekeeping of prepared reports and scheduling logs.
• Interface with ERP software systems and Microsoft products, regularly (Outlook, Word and Excel), maintaining these under protected files in the QMS or in the Document Control limited access drive.
• Immediately initiation and communication to execute corrective maintenance actions when calibrated equipment is determined to be out of specification OOS) or found to be inoperable. Coordinate with QA and Engineering areas to resolve issues associated with these correction maintenance activities.
• Interface with approved Calibration service providers in quoting, scheduling, executing, and documenting required activities in accordance with written instructions.
• Responsible for maintaining organized, complete, and accurate records for calibration, supporting Preventive Maintenance area with training or troubleshooting in data logging in activities. Will be expected to generate reports from the ERP system to document periodic reviews of activities associated with the executed tasks for preventive maintenance and calibration.
• Work with Production Leads and QC Coordinator or QE to assure equipment is maintained and located at its designated area for an easy identification and retrieval to conduct the planned equipment calibration, to avoid equipment loss or delays.
• Proper labeling and tagging of equipment, assuring clear and visible due dates.
• Assist QA/QEs in the development and improvement or creation of Calibration practices and procedures.
• Providing effective communication and additional support to Nordson MEDICAL members, as required.
• Act as an internal and external ambassador of the company, promoting a positive and cooperative image, demonstrating support and the continuous improvement attitude of the Nordson MEDICAL Quality Policy
• Comply with all applicable Nordson MEDICAL policies and procedures and maintain current training requirements.