Equipment Calibration Specialist

hace 2 semanas

Tecate, Baja California, México Nordson Corporation A tiempo completo

Job Summary

The Calibration and Maintenance Coordinator will oversee the administration and maintenance of calibration, environmental controls, and equipment maintenance records. This role ensures that all equipment and measurement tools are serviced in a timely manner, adhering to written procedures.

Key Responsibilities

  • Coordinate equipment calibration activities and records housekeeping, setting up new and managing existing equipment serial or functional profiles in the eQMS (IFS).
  • 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).
  • 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, 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.
  • 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.
  • 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 to detail.
  • Computer Skills: knowledge in navigation and use of MS Windows operating system and networks.

Working Conditions and Physical Demands

  • Must be able to sit, walk, or move throughout the office, Lab, or process, carrying small Lab, machinery, or tools.
  • Must be able to lift up to 30 pounds and stand for extended periods of time.

Travel Required

Minimal

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