Calibrator I

The Calibrator I

The Calibrator I is responsible for performing hands-on calibration and testing of FMI pumps in accordance with customer specifications, internal requirements, controlled work instructions, and applicable Quality Management System requirements. Supports production output, product quality, traceability, and documentation accuracy aligned to ISO 13485. Assigns serial numbers, documents work performed, identifies in-process issues, and escalates concerns as appropriate. May support pump assembly and cross-functional activities involving Production, Quality, Manufacturing Engineering, Global Supply Chain, Manufacturing Logistics, Commercial/Customer Service, and other departments to support investigations, corrective actions, continuous improvement, and customer requirements.

Responsibilities

• Calibrate and test FMI pumps according to customer specifications, controlled work instructions, drawings, procedures, and applicable quality requirements
• Assign serial numbers and maintain proper product identification and traceability throughout the calibration process
• Complete production and calibration records accurately, legibly, and in accordance with FMI procedures
• Support Production Associate I/II team members by assisting with work processes, knowledge sharing, and helping maintain consistent workmanship and quality standards
• Maintain a clean, organized, and safe work area in accordance with company standards Quality System and ISO 13485
• Support Follow FMI Quality Management System requirements, including applicable procedures, work instructions, training requirements, and documentation expectations
• Support FMIs transition to ISO 13485 by maintaining awareness of controlled documents, traceability, good documentation practices, nonconforming product requirements, change control expectations, and escalation processes
• Identify, communicate, and escalate in-process issues, nonconformances, process and material concerns, or documentation discrepancies to the appropriate personnel
• Recognize product or process concerns that may impact product conformity, including frozen pump heads, clogged dispensing tips, inconsistent pump performance, incorrect components, incomplete documentation, or similar issues
• Participate in training, cross-training, documentation updates, process reviews, validation support, corrective action activities, and continual improvement initiatives as requested
• Cross-Functional Support Provide accurate production history, calibration observations, process feedback, and hands-on knowledge to support root cause analysis, containment, corrective actions, and preventive actions
• Support Manufacturing Engineering and Quality in evaluating work instructions, calibration methods, tooling, fixtures, process flow, and documentation for accuracy, usability, and improvement opportunities
• Support Manufacturing Logistics and Global Supply Chain by identifying component shortages, incorrect materials, damaged components, labeling concerns, or other material-related issues that may affect calibration, assembly, traceability, or production flow
• Perform additional duties as requested by management
• Work overtime as required to meet business needs

Requirements

• Mechanically inclined, with manual dexterity and basic assembly skills
• Experience in manufacturing, assembly, calibration, testing, or a regulated production environment preferred
• Ability to read, understand, and follow work instructions, standard operating procedures, drawings, specifications, and other controlled documents
• Ability to support and instruct others on basic work processes, as appropriate

Physical Requirements

• Must be able to lift and/or move up to 50 pounds frequently
• Specific vision abilities include close, distance, color, and peripheral vision, depth perception, and ability to adjust focus