Equipment Calibration Specialist
hace 4 semanas
Job Summary
The Calibration Coordinator will oversee and maintain calibration, environmental controls, and equipment maintenance records, ensuring all equipment and measurement tools are serviced in a timely manner in accordance with written procedures.
Key Responsibilities
- Coordinate equipment calibration activities and records housekeeping for the site.
- Set up new and manage existing equipment serial or functional profiles in the eQMS (IFS), updating service status as necessary.
- Accurately file reviewed and complete equipment calibration and logged in records.
- Interact 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.
- Support Maintenance with training or troubleshooting on Preventive Maintenance scheduling plans and calibration schedules for all required equipment in the facility.
- Promote and prepare procedures for internal calibration, execution of calibration tasks in accordance with established Calibration Procedure schedules and applicable regulations (i.e. ISO17025) to ensure all equipment requiring calibration is maintained within due dates.
- Review and sign off on all calibration records to ensure requirements have been met.
- Assist in conducting equipment installation logging into IFS during qualification activities.
- Plan and coordinate with calibration and environmental control external services to ensure on-time activities are accomplished accordingly, including 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.
- Initiate and communicate 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.
- Maintain organized, complete, and accurate records for calibration, supporting Preventive Maintenance area with training or troubleshooting in data logging in activities. Generate reports from the ERP system to document periodic reviews of activities associated with executed tasks for preventive maintenance and calibration.
- Work with Production Leads and QC Coordinator or QE to ensure equipment is maintained and located at its designated area for easy identification and retrieval to conduct planned equipment calibration, avoiding equipment loss or delays.
- Properly label and tag equipment, ensuring clear and visible due dates.
- Assist QA/QEs in the development and improvement or creation of Calibration practices and procedures.
- Provide 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.
Requirements
- 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 work with teams with an active participating role.
- Ability to interpret drawings, measuring units and systems, or specifications.
- Fluent working knowledge of databases and administration (equipment management).
- Able to fluently prepare PowerPoint or XL tables or presentations over equipment or plan status results.
- Ability to self-solve practical problems.
- High level of attention.
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